Efectividad de la profilaxis antiemética en el posoperatorio de pacientes operados por cirugía de mínimo acceso

Anestesia, náuseas y vómitos postoperatorios van unidas prácticamente desde que la anestesia general se introdujo en la práctica clínica quirúrgica, y todavía en la actualidad sigue presentando una incidencia inaceptablemente alta. Con el objetivo de evaluarla efectividad de la medicación preanestésica antiemética con ondansetrón en comparación con dexametasona, en la prevención de la aparición de náuseas y vómitos postoperatorios, se realizó un estudio prospectivo, cuasiexperimental, con grupo control no equivalente en pacientes operados por cirugía de mínimo acceso en el hospital provincial general "Carlos Manuel de Céspedes″ de Bayamo, entre septiembre 2017 hasta diciembre 2020, distribuidos aleatoriamente en dos grupos de 78 pacientes cada uno: el grupo I tratado con ondansetrón, y el grupo II tratado con dexametasona. Fueron utilizados el test del Xi-cuadrado (X2), y la prueba de diferencias de proporciones, con un valor de p = 0,05; los pacientes entre 40 a 49 años de edad, el sexo femenino, ASA II, sin antecedentes de náuseas y vómitos; y con estratificación de riesgo intermedio de nausea y vómitos, fueron más frecuente en el grupo al que se le administró dexametasona. En el grupo I, el mayor número de pacientes tuvo intensidad leve y un número reducido de pacientes requirieron rescate antiemético con dimenhidrinato. En el grupo II, el mayor número de pacientes reportó intensidad moderada seguida de fuerte, requiriendo rescate antiemético. Se concluyó que la administración de ondansetrón en monoterapia es más efectiva en la prevención de la aparición de náuseas y vómitos postoperatorios que la administración de dexametasona.

Postoperative anaesthesia, nausea and vomiting have been linked practically since general anaesthesia was introduced into clinical surgical practice, and still today it continues to have an unacceptably high incidence. With the objective of evaluating the effectiveness of preanesthetic antiemetic medication with ondansetron compared to dexamethasone, in the prevention of the appearance of postoperative nausea and vomiting, a prospective, quasi-experimental study was carried out with a control group not equivalent in patients operated by minimally accessible surgery in the general provincial hospital "Carlos Manuel de Céspedes" of Bayamo. between September 2017 to December 2020, randomly distributed into two groups of 78 patients each: group I treated with ondansetron, and group II treated with dexamethasone. The Xi-square test (X2) and the proportions differences test were used, with a value of p = 0.05; patients between 40 and 49 years of age, female, ASA II, with no history of nausea and vomiting; and with intermediate risk stratification of nausea and vomiting, were more frequent in the group administered dexamethasone. In group I, the largest number of patients had mild intensity and a small number of patients required antiemetic rescue with dimenhydrinate. In group II, the largest number of patients reported moderate intensity followed by strong intensity, requiring antiemetic rescue. It was concluded that ondansetron monotherapy is more effective in preventing postoperative nausea and vomiting than dexamethasone administration.

Anestesia pós-operatória, náuseas e vômitos têm sido associados praticamente desde que a anestesia geral foi introduzida na prática clínica cirúrgica, e ainda hoje continua a ter uma incidência inaceitavelmente alta. Como objetivo de avaliar a eficácia da medicação antiemética pré-anestésica com ondansetrona comparada à dexametasona na prevenção do aparecimento de náuseas e vômitos pós-operatórios, foi realizado um estudo prospectivo, quase experimental, com um grupo controle não equivalente em pacientes operados por cirurgia minimamente acessível no hospital geral provincial "Carlos Manuel de Céspedes" de Bayamo entre setembro de 2017 a dezembro de 2020, distribuídos aleatoriamente em dois grupos de 78 pacientes cada: grupo I tratado com ondansetron e grupo II tratado com dexametasona. Foram utilizados o teste do xi-quadrado (X2) e o teste de diferenças de proporções, com valor de p = 0,05; pacientes entre 40 e 49 anos, sexo feminino, ASA II, sem história de náuseas e vômitos; e com estratificação de risco intermediário para náuseas e vômitos, foram mais frequentes no grupo que recebeu dexametasona. No grupo I, o maior número de pacientes apresentou intensidade leve e um pequeno número de pacientes necessitou de resgate antiemético com dimenidrinato. No grupo II, o maior número de pacientes relatou intensidade moderada seguida de intensidade forte, necessitando de resgate antiemético. Concluiu-se que a monoterapia com ondansetrona é mais efetiva na prevenção de náuseas e vômitos pós-operatórios do que a administração de dexametasona.

Prevalencia de medicamentos que prolongan el intervalo QT en salas de cardiología de un hospital de alta complejidad / Drug induced prolongation of Q-T interval in cardiology wards

Resumen: Antecedentes: La prevalencia del síndrome del QT largo (SQTL) producido por medicamentos es una de las reacciones adversas que en el último tiempo ha aumentado en prevalencia y mortalidad. No solamente ocurre con el uso de medicamentos para el tratamiento de cardiopatías, sino también en medicamentos con otra acción terapéutica. Objetivo: Evaluar la prevalencia del síndrome del SQTL inducido por medicamentos en salas de cardiología de un hospital de alta complejidad. Métodos: Estudio prospectivo, de tipo descriptivo y de corte transversal en 36 pacientes cardiópatas, que consistió en evaluar la frecuencia del uso de medicamentos que son capaces de producir un SQTL y la prevalencia de este efecto adverso. Los datos clínicos se recolectaron de la ficha clínica y de entrevistas con los pacientes. Se efectuó un seguimiento para detectar la aparición de prolongación del intervalo QT. Los resultados obtenidos fueron presentados por medio de estadística descriptiva (programa estadístico Statgraphics Centurion, versión XVI). No hubo estadística inferencial dada la ausencia de un grupo control. Resultados: 41,7%, de los 36 pacientes presentaron SQTL que en 86,7% de ellos fue asociado a un medicamento. Los medicamentos más frecuentemente asociados a este efecto adverso fueron Amiodarona (38,5%) y Ondansetrón (23,1%), y el factor de riesgo mayormente involucrado fue el sexo femenino (61,5%). Conclusión: Existió una alta prevalencia del uso de medicamentos que producen un SQTL, destacándose que existen medicamentos utilizados para otras patologías que también pueden producirlo.

Abstract: Background: The prevalence of the Long QT interval syndrome (LQTS) associated to drugs has increased en the last decades along with an increased mortality due to this condition. It occurs not only with drugs used to treat cardiac disease but also to other drugs. Aim: To evaluate the prevalence of drug induced LQTS in cardiology wards of a high complexity hospital. Method: This is a prospective, descriptive and cross sectional study in 36 patients with heart disease. The use of drugs known to affect the QT interval along with the frequency of LGTS were evaluated. Clincal data was obtained from clinical records and personal interviews. Patients were followed for the appearance of LQTS. Descriptive were used to present the results. No inferential statistics were used as no control group was involved (Statgraphics Centurion, version XVI). Results: 41.7% of the 36 patients developed LQTS and the association with drugs was present in 86.7% of them. The drugs most commonly identified were amiodarone (38.5%) and ondansetron (23.1%) of patients. Female geneder was the most common associated condition (61.5%). Conclusion: There was a frequent use of drugs known to produce LQTS, but other drugs may also be associated int this group of patients with heart disease admitted to intensive or intermediate care facilities.

Antiemetic Efficacy of Prophylactic Ondansetron Versus Ondansetron with Dexamethasone Combination Therapies in Women Undergoing Breast Surgeries: A Randomized Controlled Trial

Objective: To compare the prophylactic antiemetic efficacy of ondansetron monotherapy with that of the combination of ondansetron and dexamethasone in the prevention on postoperative nausea and vomiting (PONV) in breast surgeries by observing the incidence of PONV, assess the percentage of participants requiring rescue antiemetics, know the side effects of drugs, and analyze the effect of the surgical duration of breast surgeries. Methods: The group ondansetron (O) received 0.1 mg/kg IV ondansetron and the other group (ondansetron and dexamethasone combination, OD) received 0.1 mg/kg IV ondansetron and 0.1 mg/kg of dexamethasone. The incidence of PONV in the first 24 h, percentage of population receiving rescue antiemetics, surgical duration, and hemodynamic parameters were noted. Results: In the 0 h to 6 h postoperative period, 38.9% of participants of group O had PONV, whereas only 13.9% in group OD had PONV, which was statistically significant (P < .016). About 30.6% of study population in group O and 8.3% in group OD required rescue antiemetics which was statistically significant (P = .017). Surgical duration of more than 120 min had a statistically significant higher incidence of PONV in the O group with a P-value of .048. Conclusion: The combination of prophylactic ondansetron with dexamethasone is more efficacious than ondansetron alone for the prevention of PONV in women undergoing breast surgeries.

Paro cardiorrespiratorio presuntamente secundario a la administración de ondansetrón en paciente con trastorno electrolítico

El Ondansetron pertenece a una clase de medicamentos llamados antagonistas de los receptores 5HT3 con uso antiemético indicados para el control de las náuseas inducidos por la quimioterapia, radioterapia y cirugía. A este fármaco, se asociado muy pocos efectos adversos serios. Actualmente el Ondansetron ha sido relacionado con casos de arritmias ventriculares y muerte súbita. El presente caso pertenece a un paciente de sexo masculino de 67 años de edad atendido en servicio de urgencias por un cuadro de hipokalemia crónica, tratado en base a fluidoterapia, ranitidina, almodipino y ondasetron en un tiempo de 20,min, posterior a la administración de este último presenta muerte súbita.

Ondansetron belongs to a class of medications called 5HT3 receptor antagonists with antiemetic use indicated for the control of nausea induced by chemotherapy, radiotherapy, and surgery. This medication has been associated with very few serious side effects. Currently, Ondansetron has been linked to cases of ventricular arrhythmias and sudden death. This case is of a 67-year-old male patient treated in the emergency department for a chronic hypokalemia, treated with fluid therapy, ranitidine, amlodipine, and ondansetron in a time of 20 minutes, after the administration of the latter, he presented with sudden death.

An overview of preparation and characterization of solid binary system and its application on transdermal film with variation of plasticizers

Chemotherapy induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV) is a problem, often occurs in patient. Inspite of high bioavailability, the demerits such as: hepatic first pass metabolism and invasive nature of oral and parenteral dosage forms can be avoided with anti-emetic therapy of transdermal device. The major objective of the present study is to modify the hydrochloride (HCl) form of Ondansetron (OND) to the base form followed by improvement of solubility and permeability of OND by employing solid dispersion (SD) loaded patches. Preformulation study, as observed, begins with an approach to enthuse solubility of OND by SD technique choosing different carriers. The choice of carriers was rationalized by phase solubility study. Several combinations of transdermal films were prepared with pure drug, carriers and SDs with plasticizer Ka values of OND-HPßCD binary system were found lower (54.43 to 187.57 M-1) than that of OND-PVP K-30 binary system (1156.77 to 12203.6 M-1). The drug content of SDs and patches were found satisfactory. Better permeation rate (236.48±3.66 µg/3.935 cm2) with promising flux enhancement (8.30 fold) was found with DBP loaded SD patch (P6*). Hence, enhancement of solubility and permeability of P6* ensures that it can successfully enhance the bioavailability

¿Puede el fentanilo intratecal disminuir la aparición de náuseas y vómito en comparación con ondansetrón intravenoso durante cesárea electiva? Revisión sistemática de la literatura y metaanálisis / Can intrathecal fentanyl decrease the occurrence of nausea and vomiting compared with intravenous ondansetron during elective cesarean section? Literature Systematic review and meta-analysis

Elective caesarean section is one of the surgeries with the highest intraoperative incidence of nausea, retching and vomiting (IONV), due, among other causes, to the use of anesthetics during the procedure. Some clinical trials have associated the use of low-dose intrathecal (IT) fentanyl with a lower incidence of nausea, retching and vomiting compared to other anesthetics used during caesarean sections. In this context, the objective of this meta-analysis was to evaluate the decrease in the appearance of nausea and vomiting during elective caesarean section with the application of IT fentanyl when compared with the use of intravenous ondansetron (EV). A systematic search was conducted in the main databases (PubMed, EMBASE, ClinicalTrials.gov, Cochrane Library and Google Scholar) for Randomized Clinical Trials (RCTs) that evaluated the use of IT fentanyl compared to ondansetron EV to decrease the occurrence and incidence of IONV during elective caesarean section. The meta-analysis showed a reduction in the incidence of nausea (RR 0.52, 95% CI 0.29-0.93, P = 0.03), gagging (RR 0.39, 95% CI 0, 18-0.88, P = 0.02) and vomiting (RR 0.26, 95% CI 0.11-0.64, P = 0.003) in the group of patients treated with IT fentanyl compared to the group treated with EV ondansetron. From the results, it is suggested that the administration of 12.5 to 20 µg of IT fentanyl may decrease the incidence of IONV in patients undergoing elective caesarean section, although the importance of more high-quality RCTs is highlighted.

La cesárea electiva es una de las cirugías con mayor incidencia intraoperatoria de náuseas, arcadas y vómito (NAV), debido entre otras causas, al uso de anestésicos durante el procedimiento. Algunos ensayos clínicos han asociado el uso de fentanilo intratecal (IT) a dosis bajas con una menor incidencia de náuseas, arcadas y vómito en comparación con otros anestésicos usados durante las cesáreas. En este contexto el objetivo de este metaanálisis fue evaluar la disminución en la aparición de náuseas y vómito durante cesárea electiva con la aplicación de fentanilo IT al compararlo con el uso de ondansetrón intravenoso (EV). Se realizó una búsqueda sistemática en las principales bases de datos (PubMed, EMBASE, ClinicalTrials.gov, Cochrane Library y Google Scholar) para ensayos clínicos aleatorizados (ECA) que evaluaron el uso del fentanilo IT en comparación con ondansetrón EV para disminuir la aparición e incidencia de IONV durante cesárea electiva. En el metaanálisis se evidenció una reducción en la incidencia de náusea (RR 0,52, 95% IC 0,29-0,93, P = 0,03), arcada (RR 0,39, 95% IC 0,18-0,88, P = 0,02) y vómito (RR 0,26, 95% IC 0,11-0,64, P = 0,003) en el grupo de pacientes tratados con fentanilo IT comparado con el grupo tratado con ondansetrón EV. A partir de los resultados, se sugiere que la administración de 12,5 a 20 µg de fentanilo IT puede disminuir la incidencia de NAV intraoperatorias en pacientes sometidas a cesárea electiva, aunque se resalta la importancia de más ECA de alta calidad.

Utilidad del ondansetrón vs dexametasona como profilaxis antiemética posoperatoria durante la cirugía mayor ginecológica / Usefulness of ondansetron versus dexamethasone as postoperative antiemetic prophylaxis during major gynecologic surgery

Introducción: Las náuseas y vómitos posoperatorios son una secuela no deseada durante la etapa de recuperación anestésica. Objetivo: Evaluar la utilidad de la dexametasona en comparación con el ondansetrón para la prevención de las náuseas y vómitos posoperatorios después de procedimientos quirúrgicos ginecológicos mayores, bajo anestesia general orotraqueal. Método: Se realizó un estudio observacional analítico, prospectivo, en 84 pacientes mayores de 19 años, en el Hospital Clínico Quirúrgico Miguel Enríquez desde octubre de 2018 hasta septiembre de 2019, divididas de forma secuencial, en orden de llegada a la unidad quirúrgica, en dos grupos. Al grupo 1 se le administró dexametasona (4 mg endovenosa); al grupo 2 (4 mg de ondansetrón), 30 min antes de finalizar la cirugía. Resultados: Predominó de forma significativa el riesgo medio de náuseas y vómitos posoperatorios en los pacientes con edades comprendidas entre 41 y 50 años. Predominó la condición de excelente y buena (pgt;0,05) en cuanto a la efectividad del tratamiento profiláctico. La cefalea prevaleció de forma significativa en el grupo 2. La mayor parte de las pacientes no presentó eventos adversos. Conclusiones: El ondansetrón y la dexametasona son útiles para la profilaxis de las náuseas y vómitos posoperatorios en pacientes intervenidas de cirugía mayor ginecológica, bajo anestesia general orotraqueal por lo que se considera un tratamiento seguro, con eventos adversos leves y de fácil control(AU)

Introduction: Postoperative nausea and vomiting are an unwanted sequel during the anesthetic recovery stage. Objective: To evaluate the usefulness of dexamethasone compared with ondansetron for the prevention of postoperative nausea and vomiting after major gynecological surgical procedures, under general orotracheal anesthesia. Method: A prospective, analytical and observational study was carried out with 84 patients older than 19 years of age, at Miguel Enríquez Hospital Clinical-Surgical Hospital, from October 2018 to September 2019, divided sequentially, in order of arrival at the surgical unit, into two groups. The group 1 was administered dexamethasone (4 mg intravenously), and the group 2 was administered ondansetron (4 mg), 30 min before the end of the surgery. Results: The average risk of postoperative nausea and vomiting prevailed significantly among patients aged 41-50 years. Excellent and good conditions predominated (pgt;0.05) in terms of effectiveness of prophylactic treatment. Headache prevailed significantly in the group 2. Most of the patients did not present adverse events. Conclusions: Ondansetron and dexamethasone are useful for postoperative nausea and vomiting prophylaxis among patients who received major gynecological surgery, under general orotracheal anesthesia, a reason why it is considered a safe treatment, with mild adverse events and easy control(AU)

Comparison of palonosetron-dexamethasone and ondansetron-dexamethasone for prevention of postoperative nausea and vomiting in middle ear surgery: a randomized clinical trial / Comparação entre palonosetrona-dexametasona e ondansetrona-dexametasona na prevenção de náuseas e vômitos no pós-operatório de cirurgia do ouvido médio: estudo clínico randomizado

Abstract Background: Postoperative nausea and vomiting is the second most common complaint in the postoperative period after pain. The incidence of postoperative nausea and vomiting was 60-80% in middle ear surgeries in the absence of antiemetic prophylaxis. Because of this high incidence of postoperative nausea and vomiting, we aimed to assess the effect of palonosetron-dexamethasone and ondansetron-dexamethasone combination for the prevention of postoperative nausea and vomiting in patients of middle ear surgery. Methods: Sixty-four patients, scheduled for middle ear surgery, were randomized into two groups to receive the palonosetron-dexamethasone and ondansetron-dexamethasone combination intravenously before induction of anesthesia. Anesthesia technique was standardized in all patients. Postoperatively, the incidences and severity of nausea and vomiting, the requirement of rescue antiemetic, side effects and patient satisfaction score were recorded. Results: Demographics were similar in the study groups. The incidence difference of nausea was statistically significant between groups O and P at a time interval of 2-6 hours only (p = 0.026). The incidence and severity of vomiting were not statistically significant between groups O and P during the whole study period. The overall incidence of postoperative nausea and vomiting (0-24 hours postoperatively) was 37.5% in group O and 9.4% in group P (p = 0.016). Absolute risk reduction with palonosetron-dexamethasone was 28%, the relative risk reduction was 75%, and the number-needed-to-treat was 4. The patient's satisfaction score was higher in group P than group O (p = 0.016). The frequency of rescue medication was more common in group O than in group P patients (p = 0.026). Conclusion: The combination of palonosetron-dexamethasone is superior to ondansetron-dexamethasone for the prevention of postoperative nausea and vomiting after middle ear surgeries.

Resumo Justificativa: Náusea e vômito no pós-operatório é a segunda queixa pós-operatória mais frequente após a dor. Sem profilaxia antiemética, a incidência de náusea e vômito no pós-operatório foi de 60−80% após cirurgia do ouvido médio. Dada a alta incidência relatada de náusea e vômito no pós-operatório, nosso objetivo foi avaliar o efeito da combinação de palonosetrona-dexametasona e ondansetrona-dexametasona na prevenção de náusea e vômito no pós-operatório em pacientes submetidos a cirurgia do ouvido médio. Método: Sessenta e quatro pacientes programados para cirurgia de ouvido médio foram aleatoriamente divididos em dois grupos. Um recebeu a combinação de palonosetrona-dexametasona (grupo P) e o outro ondansetrona-dexametasona (grupo O) por via intravenosa antes da indução anestésica. A técnica anestésica foi padronizada em todos os pacientes. No pós-operatório, foram registradas incidência e gravidade das náuseas e vômitos, necessidade de antiemético de resgate, efeitos colaterais e índice de satisfação dos pacientes. Resultados: As características demográficas foram semelhantes nos grupos estudados. A diferença na incidência de náusea foi estatisticamente significante entre os grupos O e P apenas no intervalo de tempo entre 2 e 6 horas (p = 0,026). A incidência e gravidade de vômito não foram estatisticamente significantes entre os grupos O e P durante todo o período do estudo. A incidência geral de náusea e vômito no pós-operatório (0−24 horas de pós-operatório) foi de 37,5% no grupo O e de 9,4% no grupo P (p = 0,016). A combinação palonosetrona-dexametasona associou-se com redução do risco absoluto de 28%, redução do risco relativo de 75%, e o número necessário para tratar foi 4. O escore de satisfação do paciente foi maior no grupo P (p = 0,016). A frequência da medicação de resgate foi mais comum no grupo O (p = 0,026). Conclusão: A combinação de palonosetrona-dexametasona é superior à ondansetrona-dexametasona na prevenção da náusea e vômito no pós-operatório após cirurgia de ouvido médio.

Bioavailability Study Of Ondansetron Gel In Rabbits And Human Volunteers Appling Uplc As Analytical Tool And Evaluation Of The Antiemetic Effect Of Ondansetron Gel In Cisplatin-Induced Emesis In Rats

Objective: This study was undertaken to determine the bioavailability of ondansetron gel in experimental animals and humans applying UPLC as an analytical tool and evaluation of the antiemetic effect of ondansetron gel in cisplatin-induced emesis in rats. Methods: Ondansetron gel (F13: sodium alginate 7% w/w) was used, marketed I. V. ondansetron (Zofran) ® was chosen as reference. The bioavailability study in rabbits was selected as a parallel design using nine healthy rabbits divided into three groups whereas, bioavailability study in humans was an open-label, wherein 6 healthy subjects administered ondansetron gel. The potential effect of ondansetron gel was evaluated for the prevention of different phases of emesis motivated by exposure to antineoplastic drugs (cisplatin) by determination of body weight loss, water and food intake applying kaolin-pica model in rats using seventy-two rats divided into six groups. Results: Ondansetron gel (0.5%) showed detectable plasma concentration 22.833±2.17 ng/m1 after ¼ h and 419.55±2.17 ng/ml after 1-h post-treatment in rabbits and human respectively and concentration was maintained above-reported minimum effective concentration for more than 2.5 h for rabbits and 7 h for humans compared to 1.75 h after I. V. administration. The ondansetron gel significantly reduces all phases of cisplatin-induced emesis and a decrease in body weight, water, and food consumption was significantly attenuated. Conclusion: Based on the high efficacy of gel on emesis induced by cisplatin, and its high bioavailability, transdermal ondansetron gel could be a promising convenient system to prevent nausea and vomiting following administration of antineoplastic drugs.

Pectoralis Major Myocutaneous Flap Reconstruction in Head-and-Neck Malignancy – Experience from a Tertiary Care Center

Background: The pectoralis major myocutaneous (PMMC) flap as a pedicle flap is still a reliable option to reconstruct thedefects following major oncological resections of head-and-neck cancer. It is the workhorse in centers where the facilities forfree tissue transfer are not available. Our aim is to assess the complications of PMMC flap reconstruction.Materials and Methods: A retrospective analysis of records of 17 patients who underwent reconstruction with PMMC flapas a pedicle flap for head-and-neck malignancies from 2013 to 2019 in the Department of Surgical Oncology, GovernmentThoothukudi Medical College Hospital, Thoothukudi, was performed.Results: Records of 17 patients who received PMMC flap were taken for analysis. Of those 17 patients, three were female. Ofthose 17 patients, 15 had oral cavity malignancy and 2 had malignant parotid tumors. PMMC was used to cover the mucosaldefect in eight patients, skin defect in two patients, and both in seven patients as bipaddle flap. None of the patients had a totalloss of flap, but one case of marginal necrosis and three cases of partial intraoral flap dehiscence were noted. Oral cavity defectaccounts for 15 flaps and the remaining 2 were done to reconstruct the defect following resection of the malignant parotid tumor.Conclusion: In centers without free tissue transfer facility, PMMC is still the gold standard flap in head-and-neck reconstruction.The morbidity is very minimal in experienced hands.

A Comparison of Ondansetron, Palonosetron and Granisetron for Prevention of Post-Operative Nausea and Vomiting after Laparoscopic Surgeries.

Post-Operative Nausea and Vomiting (PONV) “the little big problem” after surgery/anaesthesia is a common side-effect which compromises the quality of care, delays discharge and thereby delays resumption of activities of daily living. A number of pharmacological agents (antihistamines, butyrophenones, dopamine receptor antagonists) have been used, and the 5‑hydroxytryptamine type 3 receptor antagonists have been found to be effective in prevention and treatment of PONV. Thus, we compared the prophylactic effects of intravenously administered ondansetron, palonosetron, and granisetron in prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgery under general anaesthesia. METHODSThis prospective, double blind study, comprising of 135 patients of ASA physical status I and II of either gender, was carried out after approval was obtained from the Institutional Ethical and Scientific Committee. Patients were randomized into three equal groups. Group P received inj. palonosetron (0.075 mg), group O received inj. ondansetron (8 mg), and group G received inj. granisetron (2.5 mg) intravenously five minutes before induction of anaesthesia. The episodes of postoperative nausea and vomiting, severity of nausea, need for rescue antiemetic, side effects and patient satisfaction were observed in the study groups for 24 hours in the post-operative period. At the end of study, results were compiled, and statistical analysis was done using ANOVA, chi‑square test, and Kruskal Wallis Test. Value of p < 0.05 was considered significant.RESULTSThe incidence of PONV was significantly less in the palonosetron group (95.6%) as compared to the ondansetron group (80%) and granisetron group (73.3%), with a lesser need for rescue antiemetic in the palonosetron group. All the three study groups did not have significant adverse effects reflecting that all the three drugs were well-tolerated. Patient satisfaction score was also more with palonosetron

¿Puede el fentanilo intratecal disminuir la aparición de náuseas y vómito en comparación con ondansetrón intravenoso durante cesárea electiva? Revisión sistemática de la literatura y metaanálisis / Can intrathecal fentanyl decrease the occurrence of nausea and vomiting compared with intravenous ondansetron during elective cesarean section? Literature Systematic review and meta-analysis

Elective caesarean section is one of the surgeries with the highest intraoperative incidence of nausea, retching and vomiting (IONV), due, among other causes, to the use of anesthetics during the procedure. Some clinical trials have associated the use of low-dose intrathecal (IT) fentanyl with a lower incidence of nausea, retching and vomiting compared to other anesthetics used during caesarean sections. In this context, the objective of this meta-analysis was to evaluate the decrease in the appearance of nausea and vomiting during elective caesarean section with the application of IT fentanyl when compared with the use of intravenous ondansetron (EV). A systematic search was conducted in the main databases (PubMed, EMBASE, ClinicalTrials.gov, Cochrane Library and Google Scholar) for Randomized Clinical Trials (RCTs) that evaluated the use of IT fentanyl compared to ondansetron EV to decrease the occurrence and incidence of IONV during elective caesarean section. The meta-analysis showed a reduction in the incidence of nausea (RR 0.52, 95% CI 0.29-0.93, P = 0.03), gagging (RR 0.39, 95% CI 0, 18-0.88, P = 0.02) and vomiting (RR 0.26, 95% CI 0.11-0.64, P = 0.003) in the group of patients treated with IT fentanyl compared to the group treated with EV ondansetron. From the results, it is suggested that the administration of 12.5 to 20 µg of IT fentanyl may decrease the incidence of IONV in patients undergoing elective caesarean section, although the importance of more high-quality RCTs is highlighted.

La cesárea electiva es una de las cirugías con mayor incidencia intraoperatoria de náuseas, arcadas y vómito (NAV), debido entre otras causas, al uso de anestésicos durante el procedimiento. Algunos ensayos clínicos han asociado el uso de fentanilo intratecal (IT) a dosis bajas con una menor incidencia de náuseas, arcadas y vómito en comparación con otros anestésicos usados durante las cesáreas. En este contexto el objetivo de este metaanálisis fue evaluar la disminución en la aparición de náuseas y vómito durante cesárea electiva con la aplicación de fentanilo IT al compararlo con el uso de ondansetrón intravenoso (EV). Se realizó una búsqueda sistemática en las principales bases de datos (PubMed, EMBASE, ClinicalTrials.gov, Cochrane Library y Google Scholar) para ensayos clínicos aleatorizados (ECA) que evaluaron el uso del fentanilo IT en comparación con ondansetrón EV para disminuir la aparición e incidencia de IONV durante cesárea electiva. En el metaanálisis se evidenció una reducción en la incidencia de náusea (RR 0,52, 95% IC 0,29-0,93, P = 0,03), arcada (RR 0,39, 95% IC 0,18-0,88, P = 0,02) y vómito (RR 0,26, 95% IC 0,11-0,64, P = 0,003) en el grupo de pacientes tratados con fentanilo IT comparado con el grupo tratado con ondansetrón EV. A partir de los resultados, se sugiere que la administración de 12,5 a 20 µg de fentanilo IT puede disminuir la incidencia de NAV intraoperatorias en pacientes sometidas a cesárea electiva, aunque se resalta la importancia de más ECA de alta calidad.

La administración de ondansetrón no mejora la evolución de los niños con gastroenteritis aguda sin deshidratación / Administration of ondansetron does not improve the course of children with acute gastroenteritis without dehydration

Sobre la base de una viñeta clínica de un niño con gastroenteritis aguda sin deshidratación, el autor de este artículo realiza una búsqueda bibliográfica para revisar la evidencia que avala el uso de ondansetrón para tratar sus vómitos, práctica bastante común en instituciones con acceso a este fármaco en sus centrales de emergencia. Luego de dicha búsqueda, el autor concluye que en niños con gastroenteritis aguda sin deshidratación, la administración de ondansetrón no reduce la necesidad de hidratación intravenosa ni la frecuencia ni la severidad de los vómitos. (AU)

Based on a clinical vignette of a child with acute gastroenteritis without dehydration, the author of this article performs a literature search to review the evidence supporting the use of ondansetron to treat his vomiting, a fairly common practice in institutions with access to this drug in their emergency rooms. After this search, the author concludes that in children with acute gastroenteritis without dehydration, the administration of ondansetron does not reduce the need for intravenous hydration or the frequency or severity of vomiting. (AU)

Formulation And Comparative Evaluation Of Ondansetron Hydrochloride Mouth Dissolving Tablets In India

Objective: The aim of the present study was to prepare the ondansetron hydrochloride Mouth Dissolving Tablets (MDTs) followed by its comparison with ethical and non-ethical (generic) marketed tablets. Methods: Prior to the formulation, drug excipient compatibility study was carried out by FTIR spectroscopy. The λmax was determined by UV spectroscopy. The ondansetron hydrochloride MDTs were prepared by direct compression method using Sodium Starch Glycolate (SSG) as super disintegrant and camphor as a sublimating agent. Then the prepared MDTs were subjected to evaluation of post compression parameters such as thickness and diameter, weight variation, wetting time, hardness, friability, disintegration and dissolution. The results obtained were compared with that of ethical and non-ethical marketed ondansetron hydrochloride 4 mg tablets. Results: The λmax was found at 310 nm. FTIR study revealed that excipients used in the prepared formulations are compatible with the drug. The thickness and diameter was in the range of 2.646 to 3.27 mm and 6.0 to 8.12 mm, respectively. Friability was in the range of 0.43 to 0.88 % and had a slightly higher friability (1.27%) for sublimated tablets. Wetting time and disintegration time were in the range of 15 to 40 sec and 23 to 50 sec, respectively. The 100 % drug release was found within 180 sec for all the codes. These results were then compared with non-ethical film coated ondansetron marketed tablets. Conclusion: Ondansetron hydrochloride MDT 4 mg tablets prepared in the laboratory were under specified IP limits. The experimental findings demonstrated that any of these ethical and non-ethical tablets of ondansetron hydrochloride can be selected, advised by the physician or pharmacist, as per the patient’s need and economical status.

Effects of Dexamethasone and Ondansetron as an Adjuvant to Bupivacaine in Supraclavicular Brachial Plexus Blocks

Background Th supraclavicular brachial plexus block (SCBPB) exhibits a good anesthetic and analgesic effect to the upper extremity below the shoulder and reduces the need for opioid consumption. Among many medications, dexamethasone and ondansetron had been used as effective adjuvants to the local anesthetics in BPB. Aim: to compare the block characteristics with dexamethasone versus ondansetron as adjuvant to bupivacaine hydrochloride (BPV) in SCBPB. Materials and methods: 75 patients were allocated and divided into three equal groups. Combined ultrasound and nerve stimulation (CUSNS) - guided SCBPB had been done. Control group (C) received thirty ml of 0,5% bupivacaine with 2 ml of normal saline. Ondansetron group (O) received thirty l of 0.5% bupivacaine with 2 ml of 4 mg of ondasetron. In dexamethasone group (D), patient received thirty ml of 0.5% BPV plus 2 ml of 8 mg dexamethasone. Results: A prolonged effect of both sensory and motor block were observed in both group D and group O (more significant in D) than group C. Total dose of analgesic (tramadol in mgs in 24 hours) was obviously reduced in group D and group O than group C. Conclusion: Dexamethasone had better effects on sensory and motor block duration in comparison with ondansetron. The first time to analgesic request in dexamethasone group was longer than ondansetron group (AU)

Formulation And Characterization Of Ondansetron Hydrochloride Matrix Tablets For Sustained Drug Delivery

The objective of proposed work was to develop Ondansetron Hydrochloride (OND HCl) sustained release matrix tablets for the better treatment of vomiting for extended period of time. Sustained release matrix tablet is the drug delivery system that is designed to achieve a prolonged therapeutic effect by continuously releasing medication over an extended period of time after administration of single dose. The matrix tablets of OND HCl were prepared by direct compression method using varying ratio of hydroxy propyl methyl cellulose (HPMC) and ethyl cellulose. The bends of tablets were evaluated for bulk and tapped density, % compressibility index and angle of repose and powder of all formulations blend exhibited that low interparticle friction and excellent flow characteristics. The prepared matrix tablets were then assessed for different physical tests like consistency of weight, thickness, hardness, friability, drug content and in vitro drug release. Each batch of the OND HCl matrix tablets were of good quality as to hardness, thickness, friability and % medicament content. The in vitro drug release study was done for 2 hours by utilizing paddle technique in 0.1N HCl (pH 1.2) as dissolution media and 6 hours using phosphate buffer (pH 6.8) as dissolution media. The drug release study showed that all formulation FMT-1, FMT-2, FMT-3, FMT-4, FMT-5 and FMT-6 were provide the drug release on sustained manner up to 8 hrs. Amongst the developed matrix tablets formulations, FMT-2 containing ethyl cellulose (100 mg) was optimized as best because FMT-2 show highest drug release profile and promoting the sustained release of drug, which could potentially improve the patient compliance.

Evaluation of the Effect of Ondansetron on Haemodynamics under Spinal Anaesthesia

Spinal anaesthesia related hypotension and bradycardia is not rare. One of the causes for post spinal hypotension is thought to be bezold-jarisch reflex (BJR) which is mediated by serotonergic 5-HT3 receptors. Ondansetron, one of the reliable drugs for nausea and vomiting, is 5-HT3 antagonist. Effect of ondansetron to attenuate hypotension has been studied in caesarean section but there is paucity of literature for general population. Aim and Objectives: In this study we aimed at evaluating the efficacy of ondansetron on haemodynamics of patients undergoing spinal anaesthesia. Methods: This prospective study enrolled 200 ASA I and II patients assigned into 2 groups: Group O (Ondansetron group, n=100) received injection ondansetron 0.1mg/kg intravenous, diluting the drug to make volume 10 ml 5 minutes prior to spinal anaesthesia(SA). Group P (Placebo group, n=100) received injection normal saline 10 ml intravenous 5 minutes prior to spinal anaesthesia. Results: Demographic data were comparable in both the groups. There was no significant difference in MAP (mean arterial pressure), HR(heart rate) & SpO2 (oxygen saturation) values in group O whereas in group P statistically significant variations in MAP, HR & SpO2 values were observed. Fewer interventions using intravenous atropine & ephedrine were required in group O as compared to group P. Conclusion: In conclusion, intravenous administration of ondansetron 5 minutes before spinal anaesthesia attenuates the decrease in mean arterial pressure.

Comparsion of Palonsteron, Ondansetron and Dexamethasone in Reduction of Post Operative Nausea and Vomiting Following Laparoscopic Cholecystectomy

The aim of the study is to compare efficacy of intravenous (i/v) Palonosetron (75mcg), i/v Ondansetron (4mg) and i/v Dexamethasone (5mg) as prophylactic agents for reducing post-operative nausea and vomiting that follows laparoscopic cholecystectomy. Methods: This prospective randomized double blind study was conducted in the Department of Anaesthesia and Critical Care, Tata Main Hospital, Jamshedpur. The study participants comprised of patients undergoing elective laparoscopic cholecystectomy surgeries under general anaesthesia. A total of 90 patients i.e. 30 in each of the three groups were enrolled for the study. Enrolled patients were randomly allocated to received with i/v Dexamethasone (5 mg) or i/v Ondansetron (4mg) or i/v Palonosetron (0.075 mg). The patients in the three groups were monitored and symptoms charted on basis of Post Operative Nausea and Vomiting (PONV) scale. Results: Palonosetron 0.075mg single intravenous dose given prior to induction of anaesthesia achieves 100% complete response with 3.33% reported side effect, and none needed rescue antiemetic. Dexamethasone 5mg single intravenous dose given prior to induction of anaesthesia achieves 93.33 % complete response with none reporting side effect and 6.67% needing rescue antiemetic. Ondansetron 4mg single intravenous dose given prior to reversal of neuromuscular blockade achieves 66.67 % complete response with 20% reporting side effect and 33.33 % needing rescue antiemetic. Conclusion: I.V. Palonosetron and Dexamethasone are equally potent and superior antiemetics than Ondansetron in the prevention of PONV in patients undergoing elective laproscopic cholecystectomy under general anaesthesia.

Arritmias provocadas por ondansetrón: Presentación de un caso / Arrhythmias caused by ondansetron: Case report

RESUMEN El ondansetrón se usa para prevenir las náuseas y los vómitos causados por la quimioterapia, radioterapia y cirugías, pertenece a los antagonistas de receptores de serotonina 5-HT3, una sustancia natural que puede causar náuseas y vómitos, y bloquea su acción. El ondansetrón viene envasado en forma de tabletas de desintegración rápida, como una solución para tomar por vía oral y en ámpulas, para su uso parenteral. Se presenta el caso de una paciente de 67 años de edad con diagnóstico de carcinoma de mama, a la cual se realizó mastectomía radical con vaciamiento axilar, y recibió quimioterapia con adriamicina, ciclofosfamida y paclitaxel; así como ondansetrón para tratar las náuseas y vómitos. La paciente presentó una taquicardia con QRS ancho después de utilizar el fármaco.

ABSTRACT The ondansetron is used to prevent nausea and vomiting caused by chemotherapy, radiotherapy and surgery, belonging to the serotonin 5-HT3 receptor antagonists, a natural substance that can cause nausea and vomiting, and it blocks its action. The ondansetron is packaged in the form of rapid disintegration tablets, as a solution to be taken orally and in ampules, for parenteral use. The case of a 67-year-old female patient is presented, with a diagnosis of breast carcinoma, who underwent radical mastectomy with axillary dissection was performed, and who received chemotherapy with adriamycin, cyclophosphamide and paclitaxel; as well as ondansetron to treat nausea and vomiting. The patient presented a wide QRS complex tachycardia after taking the drug.

A comparative evaluation of effect of intravenous premedication with ondansetron versus granisetron on hemodynamics and sensory-motor blockade produced by intrathecal hyperbaric 0.5% bupivacaine

Background: Bezold Jarisch reflex is important cause of hypotension and bradycardia which occur after spinal anaesthesia. This reflex is elicited by stimulation of peripheral serotonin receptors 5- hydroxytryptamine (5- HT3 type). These receptors have antinociceptive effect, which is confirmed by many studies.The two most commonly used 5HT3 antagonist are ondansetron and granisetrone. Very few comparative studies of the two drugs on the effect after spinal anaesthesia are available.Methods: Ninety adulted patients of either sex aged 18-58 years scheduled for elective infraumbilical surgeries were randomly allocated in three groups to receive intravenous ondansetron 4mg, granisetrone 2mg or normal saline in equal volume 5mins before spinal anesthesia. Hemodynamic changes and time to sensory motor onset and regression were evaluated.Results: There was statistically significant difference in fall of systolic diastolic and mean blood pressure among the three groups. Time to two segment regression of sensory block and time to regression to S1 was faster in ondansentron (76.6±17.2mins, 176±22mins) and granisetrone group (69±17.3mins, 165±19.2mins) in comparision to control group(77.4±24.3mins, 178±21mins) which was statistically significant also p value-0.019, 0.0001 respectively.Conclusions: The prophylactic therapy with 4mg i.v. ondansetron, given five minutes before spinal anaesthesia appears to be significantly most effective and safe for attenuating haemodynamic response after spinal anaesthesia without affecting the duration of sensory block in patients undergoing infraumbilical surgeries.