ABSTRACT
ABSTRACT Introduction: This study was performed to evaluate the degree of 3-day chemotherapy-induced nausea and vomiting (CINV) in children with cancer who received highly emetogenic chemotherapy (HEC) to ascertain the efficacy of aprepitant single-dose on dayL 1 plus granisetron and dexamethasone (DEX). Methods: This clinical trial study was conducted on 120 patients in the age range of 5 to 18 years old who received chemotherapy. Patients were divided into two groups; Group A received aprepitant at 125 mg/kg on day 1 orally, followed by 80 mg/kg daily on days 2 and 3 and Group B received a single dose of aprepitant 125 mg/kg on day 1 orally and placebo on days 2 and 3. All groups received granisetron 3 mg/m2 on day 1 and DEX on days 1 to 3. The primary and secondary endpoints were to evaluate the proportion of patients with acute, delayed and overall CINV within each group. Results: There were no significant differences between the two groups for vomiting, nausea or the use of rescue therapy. The number of patients without vomiting on day 1 was similar in both groups (96.5% vs. 98.3%, respectively; p = 0.848). Conclusion: According to the results of this study, a single dose of aprepitant 125 mg/kg was as effective as administering three doses of aprepitant on 3 days. Therefore, the use of a single dose of aprepitant in combination with other standard treatment regimens to prevent CINV in children who received HEC was safe and efficacious and can be beneficial.
Subject(s)
Humans , Child, Preschool , Child , Adolescent , Vomiting , Dexamethasone , Granisetron , Aprepitant , NauseaABSTRACT
Background: it was observed that a considerable proportion of patients undergoing surgery experience intraoperative and postoperative hypothermia and it was found that misregulation of body temperature due to anesthesia as well as the cold temperature of the operation room were the main cause
Purpose: to compare the anti-shivering effect of meperidine, hydrocortisone and granisetron after spinal anesthesia during elective cesarean section
Patients and Methods: this study presents a placebo-controlled prospective randomized blind study. Included patients were randomly [using computer generated randomization table] allocated into four equal groups each group consists of 28 patients
Results: in our study, age, sex, and ASA grade distribution of patients were nearly identical in the four groups. Furthermore, the duration of surgery and amount of irrigation fluid used in the four different groups were also similar. We did not observe a change in temperature gradient between the four groups. A study with a more prolonged duration of postoperative temperature monitoring is needed to note if core-periphery temperature changes occur with passage of time
Conclusion: the results indicate that IV granisetron 40 micro g/kg was effective as IV meperidine 0.4 mg/kg and both are slightly effective than IV hydrocortisone 2 mg/kg in reducing the incidence and intensity of shivering during spinal anesthesia compared to control group
Subject(s)
Humans , Female , Adult , Hydrocortisone/pharmacology , Granisetron/pharmacology , Meperidine/pharmacology , Anesthesia, Spinal , Cesarean Section , Prospective Studies , Body TemperatureABSTRACT
BACKGROUND: The patients receiving hematopoietic stem cell transplantation (HSCT) are known to have a high incidence of breakthrough nausea and vomiting due to the conditioning regimen. The purpose of this study was to evaluate the adequacy of antiemetic therapy for breakthrough nausea and vomiting in patients receiving HSCT and to propose an effective treatment regimen. METHODS: We retrospectively reviewed the electronic medical records of 109 adult patients. The collected data were used to identify (1) antiemetic and dosing regimens prescribed for controlling breakthrough nausea and vomiting, (2) the rate of patients who developed breakthrough nausea and vomiting, and (3) the percent of antiemetics prescribed on the day of symptom onset. Based on the National Comprehensive Cancer Network guideline, we assessed the suitability of antiemetics for breakthrough nausea and vomiting, and prescription timing. RESULTS: All patients were prescribed pro re nata antiemetics. About 40.0%, 41.4%, and 18.6% of patients were using one, two, and three or more additional drugs for breakthrough nausea and vomiting, respectively. The most frequently administered drugs were intravenous metoclopramide (43.8%) and granisetron patch (36.2%). Breakthrough nausea and vomiting occurred in 87 patients (79.1%) and they developed symptoms 320 cases. About 220 cases (68.8%) were treated with additional antiemetics on the day of symptom onset and the rate of symptom resolution was only 10.3% (9 patients). CONCLUSION: The breakthrough nausea and vomiting in patients receiving HSCT occurred very frequently and was hard to control, thus requiring more rapid and aggressive treatments.
Subject(s)
Adult , Humans , Antiemetics , Electronic Health Records , Granisetron , Hematopoietic Stem Cell Transplantation , Hematopoietic Stem Cells , Incidence , Metoclopramide , Nausea , Prescriptions , Retrospective Studies , VomitingABSTRACT
Abstract Background and objectives Reducing pain on injection of anesthetic drugs is of importance to every anesthesiologist. In this study we pursued to define if pretreatment by granisetron reduces the pain on injection of etomidate similar to lidocaine. Methods Thirty patients aged between 18 and 50 years of American Society of Anesthesiologists physical status class I or II, whom were candidates for elective laparoscopic cholecystectomy surgery were enrolled in this study. Two 20 gauge cannulas were inserted into the veins on the dorsum of both hands and 100 mL of normal saline was administered during a 10 min period from each cannula. Using an elastic band as a tourniquet, venous drainage of both hands was occluded. 2 mL of granisetron was administered into one hand and 2 mL of lidocaine 2% at the same time into the other hand. One minute later the elastic band was opened and 2 mL of etomidate was administered to each hand with equal rates. The patients were asked to give a score from 0 to 10 (0 = no pain, 10 = severe pain) to each the pain sensed in each hand. Results Two patients were deeply sedated after injection of etomidate and unable to answer any questions. The mean numerical rating score for injection pain of intravenously administered etomidate after intravenous granisetron was 2.3 ± 1.7, which was lower when compared with pain sensed due to intravenously administered etomidate after administration of lidocaine 2% (4.6 ± 1.8), p < 0.05. Conclusion The result of this study demonstrated that, granisetron reduces pain on injection of etomidate more efficiently than lidocaine.
Resumo Justificativa e objetivos A redução da dor causada pela injeção de anestésicos é importante para todos os anestesiologistas. Neste estudo buscamos definir se o pré-tratamento com granisetrona reduz a dor causada pela injeção de etomidato de forma semelhante à lidocaína. Métodos Trinta pacientes entre 18 e 50 anos, estado físico ASA I ou II (de acordo com a classificação da Sociedade Americana de Anestesiologistas) e candidatos à colecistectomia laparoscópica eletiva foram incluídos neste estudo. Duas cânulas de calibre 20 foram inseridas nas veias do dorso de ambas as mãos e 100 mL de soro fisiológico foram administrados durante 10 minutos através de cada cânula. Com um torniquete elástico, a drenagem venosa de ambas as mãos foi ocluída. Granisetrona (2 mL) foi administrado em uma das mãos e lidocaína a 2% (2 mL) na outra mão ao mesmo tempo. Após um minuto, o torniquete foi afrouxado e 2 mL de etomidato foram administrados em velocidade igual a cada uma das mãos. Solicitamos dos pacientes uma classificação de 0 a 10 para a dor sentida em cada uma das mãos (0 = sem dor, 10 = dor intensa). Resultados Dois pacientes estavam profundamente sedados após a injeção de etomidato e, portanto, incapazes de responder a qualquer pergunta. O escore médio de classificação da dor à injeção de etomidato administrado por via endovenosa após granisetrona intravenoso foi de 2,3 ± 1,7, o que foi menor em comparação com a dor sentida à administração intravenosa de etomidato após a administração de lidocaína a 2% (4,6 ± 1,8), p < 0,05. Conclusão O resultado deste estudo demonstrou que granisetrona reduz a dor causada pela injeção de etomidato com mais eficácia do que lidocaína.
Subject(s)
Humans , Male , Female , Adult , Pain/chemically induced , Pain/drug therapy , Granisetron/therapeutic use , Anesthetics, Intravenous/adverse effects , Etomidate/adverse effects , Pain Management/methods , Lidocaine/therapeutic use , Double-Blind Method , Injections, Intravenous , Middle AgedABSTRACT
Palonosetron is a 5-hydroxytryptamine-3 (5-HT-3) receptor antagonist used for preventing postoperative nausea and vomiting. Compared with ondansetron and granisetron, it is a better drug because of prolonged action and minimal side effects. Some adverse effects of palonosetron have been reported. In this report, we describe a 37-year-old male who developed severe hypersensitivity reactions to palonosetron during surgery for kidney donation. His medical history was unremarkable, except for inguinal hernia with herniorrhaphy 8 years ago. The surgery was uneventful until 2 hours 20 minutes. After palonosetron injection, his blood pressure dropped to 80/50 mm Hg, and facial edema, rash, conjunctival swelling, and wheezing developed. The patient was resuscitated by administration of ephedrine, hydrocortisone, and peniramine. Following the surgery, the patient was monitored for 3 days, and there were no subsequent anaphylactic reactions or other complications. The skin test on postoperative day 54 was positive for hypersensitivity to palonosetron. Although palonosetron is known for its safety, other hypersensitivity events have been reported. Ondansetron is another widely used 5-HT-3 antagonist, which has been reported to cause anaphylaxis. Therefore, clinicians should be aware of the possibility of patients experiencing severe adverse reactions to palonosetron.
Subject(s)
Adult , Humans , Male , Anaphylaxis , Anesthesia, General , Blood Pressure , Drug Hypersensitivity , Edema , Ephedrine , Exanthema , Granisetron , Hernia, Inguinal , Herniorrhaphy , Hydrocortisone , Hypersensitivity , Kidney , Ondansetron , Postoperative Nausea and Vomiting , Respiratory Sounds , Skin TestsABSTRACT
BACKGROUND/AIMS: Serotonin receptor (eg, 5-HT₃) antagonists are used to treat nausea and vomiting from a variety of causes. Granisetron transdermal system (GTS) is an appealing delivery system for patients with gastroparesis. To assess if GTS improves nausea and vomiting and other gastroparesis symptoms in patients with gastroparesis. METHODS: Patients with gastroparesis and symptoms of nausea and vomiting refractory to conventional treatment were treated with GTS. Symptoms of gastroparesis were assessed using a modified Gastroparesis Cardinal Symptom Index (GCSI). Following 2 weeks of treatment, patients were asked to assess their symptoms and indicate their therapeutic response using the Clinical Patient Grading Assessment Scale (CPGAS) reporting if symptoms of nausea and vomiting improved on a scale: 0 = no change to +7 = completely better. RESULTS: Fifty-one patients received GTS by prescription: average age was 40 ± 17 years, 44 female, 11 diabetics, 23 ± 20% retention at 4 hours on gastric emptying scintigraphy. Thirty-nine of the 51 (76%) patients stated improvement with GTS. There was significant improvement in nausea and vomiting as assessed with CPGAS at 2 weeks (2.28 ± 2.53; P < 0.05). Symptoms of nausea and vomiting significantly improved. Other symptoms including postprandial fullness, loss of appetite, upper abdominal pain, and early satiety improved. Side effects reported included redness at the site of the patch in 7 patients, pruritus in 5, and constipation in 5. CONCLUSIONS: GTS was moderately effective in reducing nausea and/or vomiting in 76% of gastroparesis patients. In addition to nausea and vomiting, symptoms of postprandial fullness, loss of appetite, upper abdominal pain, and early satiety also improved.
Subject(s)
Female , Humans , Abdominal Pain , Appetite , Constipation , Gastric Emptying , Gastroparesis , Granisetron , Nausea , Prescriptions , Pruritus , Radionuclide Imaging , Serotonin , VomitingABSTRACT
OBJECTIVES: To compare the efficacy of intravenous ondansetron (4 mg, 2 mL) and granisetron (2 mg, 2 mL) for preventing postoperative nausea and vomiting (PONV) in patients during oral and maxillofacial surgical procedures under general anesthesia. MATERIALS AND METHODS: A prospective, randomized, and double blind clinical study was carried out with 60 patients undergoing oral and maxillofacial surgical procedures under general anesthesia. Patients were divided into two groups of 30 individuals each. Approximately two minutes before induction of general anesthesia, each patient received either 4 mg (2 mL) ondansetron or 2 mg (2 mL) granisetron intravenously in a double blind manner. Balanced anesthetic technique was used for all patients. Patients were assessed for episodes of nausea, retching, vomiting, and the need for rescue antiemetic at intervals of 0-2, 3, 6, 12, and 24 hours after surgery. Incidence of complete response and adverse effects were assessed at 24 hours postoperatively. Data was tabulated and subjected to statistical analysis using the chi-square test, unpaired t-test, or the Mann-Whitney U-test as appropriate. A P-value less than 0.05 was considered statistically significant. RESULTS: There was no statistically significant difference between the two groups for incidence of PONV or the need for rescue antiemetic. Both study drugs were well tolerated with minimum adverse effects; the most common adverse effect was headache. The overall incidence of complete response in the granisetron group (86.7%) was significantly higher than the ondansetron group (60.0%). CONCLUSION: Granisetron at an intravenous dose of 2 mg was found to be safe, well tolerated, and more effective by increasing the incidence of complete response compared to 4 mg intravenous ondansetron when used for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia. Benefits of granisetron include high receptor specificity and high potency, which make it a valuable alternative to ondansetron.
Subject(s)
Humans , Anesthesia , Anesthesia, General , Double-Blind Method , Granisetron , Headache , Incidence , Nausea , Ondansetron , Postoperative Nausea and Vomiting , Prospective Studies , Sensitivity and Specificity , Surgery, Oral , VomitingABSTRACT
OBJECTIVE: There is no research regarding the appropriate antiemetic agents for female patients, especially those receiving moderately emetogenic chemotherapy (MEC). We evaluated the antiemetic efficacy of a combination of 5-HT3 receptor with/without aprepitant in patients with gynecological cancer treated with the TC (paclitaxel and carboplatin) regimen of MEC. METHODS: We enrolled 38 patients diagnosed with gynecologic cancer and scheduled to receive the TC regimen. The patients were randomly assigned to receive a 5-HT3 receptor antagonist, either palonosetron in the first cycle followed by granisetron in the second cycle or vice versa. In the third cycle, all patients received a combination of the 5-HT3 receptor and dexamethasone with/without aprepitant. RESULTS: When three drugs were administered, palonosetron consistently produced an equivalent complete response (CR) rate to granisetron in the acute phase (89.5% vs. 86.8%, p=0.87) and delayed phase (60.5% vs. 65.8%, p=0.79). With regard to the change in dietary intake, palonosetron exhibited similar efficacy to granisetron in the acute phase (92.1% vs. 89.4%, p=0.19) and delayed phase (65.7% vs. 68.4%, p=0.14). However, in the delayed phase, the addition of aprepitant therapy with a 5-HT3 receptor antagonist and dexamethasone produced a higher CR rate than a 5-HT3 receptor antagonist with dexamethasone (93.3% vs. 47.8%, p<0.001) and allowed the patients to maintain a higher level of dietary intake (93.3% vs. 56.5%, p<0.001). CONCLUSION: The addition of aprepitant therapy was more effective than the control therapy of a 5-HT3 receptor antagonist, and dexamethasone in gynecological cancer patients treated with the TC regimen.
Subject(s)
Adult , Aged , Female , Humans , Middle Aged , Antiemetics/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carboplatin/administration & dosage , Cross-Over Studies , Diet , Drug Administration Schedule , Genital Neoplasms, Female/drug therapy , Granisetron/administration & dosage , Isoquinolines/administration & dosage , Morpholines/administration & dosage , Nausea/chemically induced , Paclitaxel/administration & dosage , Quinuclidines/administration & dosage , Serotonin 5-HT3 Receptor Antagonists , Vomiting/chemically inducedABSTRACT
Orally disintegrating systems have carved a niche amongst the oral drug delivery systems due to the highest compliance of the patients, especially the geriatrics and pediatrics. In addition, patients suffering from dysphagia, motion sickness, repeated emesis and mental disorders prefer these medications because they cannot swallow large quantity of water. Further, drugs exhibiting satisfactory absorption from the oral mucosa or intended for immediate pharmacological action can be advantageously formulated in these dosage forms. However, the requirements of formulating these dosage forms with mechanical strength sufficient to withstand the rigors of handling and capable of disintegrating within a few seconds on contact with saliva are inextricable. The purpose of this research was to mask the bitter taste of granisetron hydrochloride. To mask the taste Kollicoat(r) Smartseal 30D was used as coating polymer for pellet coating. The coated pellets of the drug was directly compressed with different superdisintegrant as AC-Di-Sol, Explotab and Kollidon CL in different concentration 5.0-7.5% w/w into an ODT. The prepared tablets were evaluated for hardness, friability, weight variation, wetting time, wet absorption ratio, in-vitro disintegration time and in vitro dissolution studies. Tablets exhibited quick disintegration characteristics with Kollidon CL in concentration 7.5% w/w i.e., within 20 seconds, which is characteristic of orally disintegrating dosage forms. More than 98% of drug was released from the formulations within 15 minutes. Formulations subjected to stability testing as per the ICH guidelines for 3 months, indicated stability with no change in taste, hardness, drug content, disintegration time and dissolution profiles. Thus, the results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated dosage forms in the oral cavity.
Sistemas de desintegração oral têm um nicho entre os sistemas de administração de medicamentos por via oral devido à maior aceitação dos pacientes, especialmente os de geriatria e pediatria. Além disso, pacientes que sofrem de disfagia, enjoo de movimento, emese repetida e distúrbios mentais preferem estes medicamentos porque não podem engolir grande quantidade de água. Além disso, os fármacos que exibem absorção satisfatória a partir da mucosa oral ou que se destinam a ação farmacológica imediata podem ser vantajosamente formulados nestas formas de dosagem. No entanto, a formulação destas formas farmacêuticas exige-lhes resistência mecânica suficiente para suportar os rigores do manuseio e capacidade de desintegrar dentro de alguns segundos em contato com a saliva. O objetivo desta pesquisa foi o de mascarar o gosto amargo de cloridrato de granisetrona. Para mascarar o sabor, utilizou-se Kollicoat smartseal 30D como polímero para io revestimento dos péletes. Os péletes revestidos do fármaco foram diretamente comprimidos com superdesintegrante diferente como Ac-Di-Sol, Explotab e Kollidon CL, em diferentes concentrações 5.0-7.5% m/m em comprimidos de dispersão oral (ODT). Os comprimidos preparados foram avaliados quanto à dureza, friabilidade, variação de peso, ao tempo de umedecimento, à razão de absorção de umidade, ao tempo de desintegração in vitro e em estudos de dissolução in vitro. Os comprimidos apresentaram características de desintegração rápida com Kollidon CL, em concentração de 7,5% m/m, ou seja, dentro de 20 segundos, o que é característico para formas farmacêuticas de desintegração oral. Mais do que 98% do fármaco foi liberado a partir das formulações no prazo de 15 minutos. Formulações submetidas a testes de estabilidade de acordo com as diretrizes da ICH por 3 meses indicaram estabilidade sem alteração no sabor, dureza, teor de fármaco, tempo de desintegração e perfis de dissolução. Assim, os resultados demonstraram que o mascaramento de gosto foi bem-sucedido e atingiu-se rápida desintegração das formas de dosagem na cavidade oral.
Subject(s)
Tablets/pharmacokinetics , Chemistry, Pharmaceutical , Granisetron/analysis , Administration, Buccal , Drug Administration RoutesABSTRACT
The incidence of pain reported in literature after IV administration of rocuronium is 50-80%. The aim of our study was to determine whether pre-treatment with intravenous granisetron and nitroglycerine would reduce rocuronium-induced pain. One hundred fifty patients of either sex, aged 18-65 years, American society of Anaesthesiologist grading [ASA] I-II, scheduled for various surgeries under general anesthesia were randomly assigned to one of the groups. Group G: received 2 granisetron [1mg/ml] diluted with 3 ml of 0.9% normal saline] while the Group C: received 5 ml of 0.9% normal saline. Group N: received 200 micro g of nitroglycerine diluted to a total of 5 ml[with 0.9% normal saline]. It was accompanied by manual venous occlusion for 20 seconds. Then 0.06mg/kg of rocuronium was injected through same cannula over 10-15 sec.Patients were asked by a blinded investigator to score the pain on injection of rocuronium using visual analogue scale [0-10] with 0-no pain,1-3 mild pain, 4-6 moderate and >=7 severe pain. At the same time discomfort in the form of patient's movement, such as no movement [grade 0], movement only wrist [grade 1], movement to the upper arm and shoulder of injected arm [grade 2] or generalized movements [grade3] was observed. Statistical analysis using independent t test, Mann-Whitney test and reverse ANOVA was done. 1. At 0 seconds, in group G number of patients who experienced with drawl score of 0-1 were 92%,group N were 82% while only 26% of patients in group C had favourable with drawl score.74% of patients in group C had score of 2-3 at same time. 2. At 0 sec, in group G number of patients who experienced VAS score of 0-3 were 96%, group N 72%. At same time Group C 48% of patients had VAS score of 2-3. We conclude that pre-treatment with granisetron or nitroglycerine both are highly effective in attenuation of rocuronium induced pain
Subject(s)
Humans , Female , Male , Granisetron , Pain/prevention & control , Double-Blind Method , Anesthesia, General , Preanesthetic MedicationABSTRACT
Postoperative nausea and vomiting [PONV] are frequently encountered after thyroidectomy. For PONV prevention, selective serotonin 5-hydroxytryptamine type 3 [5-HT [3]] receptor antagonists are considered one of the first-line therapy. We report on the efficiency of granisetron and tropisetron, with that of placebo on the prevention of PONV in patients undergoing total thyroidectomy. One hundred twenty-seven patients were divided into three groups and randomized to receive intravenously, prior to induction of anesthesia, tropisetron 5 mg, or granisetron 3 mg, or normal saline. All patients received additionally 0.625 mg droperidol. All episodes of postoperative PONV during the first 24 h after surgery were evaluated. Nausea visual analogue scale [VAS] score was lower in tropisetron and granisetron groups than the control group at all measurements [P<0.01] except for the 8-h measurement for tropisetron [P=0.075]. Moreover, granisetron performed better than tropisetron [P<0.011 at 4 h and P<0.01 at all other points of time] apart from the 2-h measurement. Vomiting occurred in 22.2%, 27.5%, and 37.5% in granisetron, tropisetron, and control groups, respectively [P=0.43]. The combination of the 5-HT[3] antagonists with droperidol given before induction of anesthesia is well tolerated and superior to droperidol alone in preventing nausea but not vomiting after total thyroidectomy
Subject(s)
Humans , Female , Male , Granisetron , Indoles , ThyroidectomyABSTRACT
Background Granisetron is a first-generation 5-HT3-receptor antagonist that has shown efficacy in preventing postoperative nausea and vomiting [PONV]. In this randomized double-blind parallel-group clinical trial, we assessed the efficacy of generic granisetron versus Kytril[registered], in the prevention of PONV in patients undergoing general anesthesia for gynaecological surgeries. Method One hundred and twenty patients who were supposed to undergo major gynaecological surgeries [myomectomy and hysterectomy] in Dr. Shariati Teaching Hospital, Tehran, Iran were randomly assigned to either single dose generic granisetron [40 mcg/kg], or Kytril[registered] [40 mcg/kg] at the end of the surgery. Two episodes of emetic symptoms [nausea and vomiting] were recorded by a gynaecologist who had no knowledge of which treatment each patient had received. This gynaecologist observed the patients at three different intervals: 6, 12 and 18 h post surgery. At the end of the observation period each patient evaluated the satisfaction with the study drug, and the gynaecologist evaluated sedation of the patients. Results In the generic granisetron group 47 and 13 patients, and in the Kytril[registered] group 45 and 15 patients underwent hysterectomy and myomectomy respectively. No difference was observed between two treatment groups regarding postoperative nausea and vomiting control during 18 hours after the drugs administration. Also there were no differences in the satisfaction with the study drug between the generic granisetron and Kytril[registered]. No difference in sedation scores was observed between two groups. Conclusion Generic granisetron exerts efficacy against PONV after gynaecological surgeries which is non-inferior to that of Kytril[registered]
Subject(s)
Humans , Female , Adult , Middle Aged , Aged , Granisetron , Drugs, Generic , Gynecologic Surgical ProceduresABSTRACT
Propofol has the disadvantage of causing pain or discomfort on injection. The aim of the study was to assess the efficacy of pretreatment with various drugs to alleviate the propofol injection pain. One hundred American Society of Anesthesiology [ASA] I and II adults, scheduled for various elective surgical procedures under general anesthesia [GA], were included in the study. They were randomly divided into four groups having 25 patients in each group. Group A received pretreatment with intravenous [i.v.] magnesium sulfate, group B received i.v. granisetron, group C received i.v. nitroglycerine and group D was the control group. One-fourth of the total calculated induction dose of propofol was administered over a period of 5 seconds. The patients were asked about the pain on injection. The intensity of pain was assessed using verbal response. A score of 0-3 which corresponds to no, mild, moderate and severe pain was recorded. All the three drugs reduced the incidence and intensity of pain on propofol injection but the order of efficacy in attenuation of pain on the propofol injection was granisetron > nitroglycerine > magnesium sulfate > control. Granisetron was the most effective followed by nitroglycerine and magnesium sulfate in attenuating pain on propofol intravenous injection
Subject(s)
Humans , Male , Female , Injections, Intravenous/adverse effects , Pain/etiology , Granisetron , Magnesium Sulfate , Analgesia/methods , Treatment Outcome , Random AllocationABSTRACT
BACKGROUND: Postoperative nausea and vomiting (PONV) remains a challenge for patients and health professionals despite various newly developed prophylactic interventions. We reviewed the efficacy and safety of ramosetron in randomized controlled trials (RCTs) for the prevention of PONV. METHODS: We reviewed 18 randomized controlled trials investigating the efficacy and safety of ramosetron in comparison with placebo or any other drugs. Relevant studies were searched in the MEDLINE, SCOPUS, and the Cochrane database libraries. Our end points of concern were prevention of PONV and adverse effects as dichotomous data. RESULTS: The prophylactic effect of 0.3 mg ramosetron was observed in early PON (relative risk, RR: 0.4; 95% CI 0.3-0.6), early POV (RR: 0.3; 95% CI 0.1-0.6), late POV (RR: 0.3; 95% CI 0.1-0.6), but not late PON (RR: 0.7; 95% CI 0.5-1.0). Compared with placebo, the efficacy of 0.3 mg ramosetron in adults and 6 microg/kg in children were consistently beneficial in preventing PONV overall (RR: 0.4; 95% CI: 03-0.6). The effects of 0.3 mg ramosetron and 3 mg granisetron were similar. No serious side effects or adverse events resulted from ramosetron and other active drugs, and incidence was similar to those of the placebo group. CONCLUSIONS: Ramosetron is effective and safe in children and adults without serious adverse effects compared with placebo or other active drugs, as shown in pooled data of RCTs, in terms of the prevention of PONV.
Subject(s)
Adult , Child , Humans , Antiemetics , Benzimidazoles , Granisetron , Health Occupations , Incidence , Postoperative Nausea and VomitingABSTRACT
<p><b>OBJECTIVE</b>To compare the efficacy of ondansetron and granisetron in the prevention of postoperative nausea and vomiting (PONV) in high-risk patients.</p><p><b>METHODS</b>Totally 200 patients with three key risk factors for PONV (female, non-smoking and postoperative opioid use) were equally randomized into ondansetron group and granisetron group. Ondansetron (4 mg) or granisetron (3 mg) was intravenously administered upon the completion of surgery. The episodes of nausea and vomiting were observed for 24 hours after surgery.</p><p><b>RESULTS</b>A significantly greater proportion of patients in granisetron group achieved a complete response (i.e., no PONV or rescue medication) during the first 24 hours postoperatively versus those in ondansetron group (62.6% vs. 46.9%, respectively; P=0.048). There were no significant differences in terms of postoperative nausea incidences (42.9% vs. 34.3%, respectively), postoperative vomiting incidences (25.5% vs. 20.2%, respectively) and postoperative rescue anti-emetics incidences (19.4% vs. 15.2%, respectively) (P>0.05).</p><p><b>CONCLUSION</b>Granisetron is more effective than ondansetron in preventing PONV in high-risk patients during the first 24 hours postoperatively.</p>
Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Antiemetics , Therapeutic Uses , Double-Blind Method , Granisetron , Therapeutic Uses , Ondansetron , Therapeutic Uses , Postoperative Nausea and Vomiting , Treatment OutcomeABSTRACT
Evaluar y caracterizar el abordaje farmacoterapéutico antiemético en el periodo postoperatorio en pacientes adultos sometidos a cirugía en el Hospital Clínica Bíblica, hospital privado en Costa Rica. Métodos: Se seleccionaron pacientes, con edades entre 18 y 75 años, sometidos a cirugía, en quienes se había utilizado algún antiemético profiláctico al proceso quirúrgico, excluyéndose los pacientes que permanecieran hospitalizados menos de 24 horas tras la cirugía. Resultados: Dentro de la terapia profiláctica antiemética utilizada en este Hospital, se incluyó: granisetrón, metoclopramida, dexametasona, dimenhidrinato, entre otros; el granisetrón fue el antiemético más utilizado en un 81 por ciento de los casos, solo o en combinación. El uso de la dexametasona junto con el granisetrón fue la combinación más utilizada en un 57 por ciento. Sin hacer asociación al procedimiento quirúrgico, las náuseas y vómitos postoperatorios se presentaron en un 12 por ciento con el granisetrón, en un 25 por ciento con la metoclopramida, en un 9 por ciento con el dimenhidrinato, en un 13 por ciento con la dexametasona y en un 14 por ciento con otros antieméticos. Las cirugías que presentaron más incidencia de NVPO fueron las cirugías ortopédicas en un 30 por ciento, y las cirugías laparoscópicas en un 28 por ciento. En los casos en los que se utilizó fentanyl como anestésico, se presentaron vómitos en un 18 por ciento de los pacientes, mientras que en los casos en que no se utilizó fentanyl, el porcentaje de NVPO fue del 9 por ciento. Conclusión: A pesar del amplio uso de antieméticos profilácticamente, las náuseas y vómitos postoperatorios siguen presentándose en los pacientes de este Hospital. No se ha encontrado un algoritmo que permita prevenir totalmente las náuseas y vómitos postoperatorios, a pesar de la gran cantidad de conocimientos adquiridos en este campo. Se debe tomar en cuenta el riesgo individual de cada paciente y la satisfacción de este...
To evaluate and characterize the pharmaco-therapeutic approach with antiemetics during the postoperative, in adult patients undergoing surgery at a private hospital in Costa Rica(Hospital Clinica Biblica) Methods: This is an observational, prospective and cohort study. Those patients who had surgery and received antiemetic prophylaxis before the procedure were selected (ages between 18 and 75 years) excluding those who had hospitalization shorter than 24 hours.Results: Prophylactic antiemetic therapy in this private hospital utilizes granisetron, metoclopramide, dexamethasone, and dimenhydrinate, Granisetron, either alone or incombination, was the most used antiemetic in 81%. The combination most commonly used was dexamethasone and granisetron (57%). Without considering the surgical procedure, the incidence of postoperative nausea and vomiting (PONV) was 12% in patients taking granisetron, 25% with metoclopramide, 9% with dimenhydrinate, 13% with dexamethasone and 14% with otherantiemetics. On the other hand, looking at the procedure, the incidence of PONV in patients undergoing orthopedic surgery was by 30%, and 28% in those after laparoscopic surgery Finally,in cases in which fentanyl was used as an anesthetic 18% of the patients presented PONV, whereas in patients cases were fentanyl was not used, the rate of was 9%. Conclusion: Despite the widespread use of prophylactic antiemetics, PONV is still seen in thepatients at this private hospital. In spite of the wealth of knowledge in this field, physicians have not yet found an algorithm capable of the total prevention of PONV. Individual risks and patient`s satisfaction should be taken into account. Further research on this matter must continue in orderto unify and improve criteria of PONV treatment.
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Antiemetics/analysis , Antiemetics/therapeutic use , Dexamethasone , General Surgery , Granisetron , Metoclopramide , Postoperative Nausea and Vomiting/drug therapy , Postoperative Complications , Costa RicaABSTRACT
INTRODUCCIËN: Las náuseas y vómitos por quimioterapia (NVIQ) constituyen una complicación importante. La introducción de los antiserotoninérgicos 5HT3 (AR 5HT3 ) unida a los esteroides, ha posibilitado un mayor control de estos síntomas. OBJETIVO: evaluar económicamente dos alternativas para el tratamiento antiemético en cáncer. MÉTODOS: se utilizaron varias técnicas de evaluación económica para dos alternativas de tratamiento antiemético. Para la primera línea, la técnica de minimización de costos (MC), que incluyó los esquemas de granisetron más dexametasona y ondansetron más dexametasona. El análisis de costoefectividad (ACE) evaluó el tratamiento alternativo después del fallo del esquema que contiene ondansetron, se realizaron los análisis de relación costo-efectividad medio (ACEM) y costo-efectividad incremental (ACEI). También análisis de sensibilidad. RESULTADOS: para los esquemas de tratamientos utilizados en la primera línea por cada paciente tratado, se logró un ahorro de $0,76 en la quimioterapia moderadamente emetógena (QME) y la quimioterapia altamente emetógena (QAE). En el ACEM, la opción que utilizó ondansetron como tratamiento de segunda línea para la QME es de $22,77 y de $4,034 para el esquema que utilizó el granisetron, para cada caso controlado. La terapia para QAE que utilizó ondansetron necesita $ 65,41 y la opción que utilizó granisetron $ 13,45, para cada paciente controlado respectivamente. En el ACEI se obtuvo un resultado no satisfactorio para el esquema que contiene ondansetron de $1,490/ caso adicional controlado en la QME y de $3,140/ caso adicional controlado para la QAE. CONCLUSIONES: el tratamiento antiemético que produjo mayor ahorro económico como terapia antiemética de primera línea es el que utilizó ondansetron, y en segunda línea el esquema que utilizó granisetron
INTRODUCTION: the occurrence of nauseas and vomiting from chemotherapy are a significant complication. With appearance of antiserotoninergics 5HT3 (AR 5HT3) combined with steroids, have allowed a great control of these symptoms. OBJECTIVE: The aim of present paper is to asses in a economic way two alternatives for antiemetic tratment in cancer. METHODS: Some techniques of economical assessment to two alternatives of antiemetic treatment were used. For the first line, the cost minimization (CM) technique including the Granisetron hydrochloride schemes plus Dexamethasone and Ondansetron hydrochloride plus Dexamethasone. The cost-effectiveness analysis (CEA) assessed the alternative treatment after the scheme failure containing Ondansetron; we performed mean cost-effectiveness (MCE) and incremental cost-effectiveness (ICE) analyses, as well as the sensitivity analysis. RESULTS: For the treatment schemes used in the first line by patient with treatment, it is possible to achieve a saving of $0.76 in the moderately emethogenic chemotherapy (MECM) and the highly emethogenic chemotherapy (HECT). In MCE, the option using Ondansetron as a second line treatment for MECM is of $22.77 and of $4.034 for scheme uses Granisetron for each controlled case. Therapy for HECT using Ondansetron needs percent65,41 and option using Granisetron needs $13.45 for each controlled patient, respectively. In the case of ICE a non-satisfactory result of $1.490 for scheme containing Ondansetron/controlled additional case in MECM, and of $3.140/controlled additional case for HECT. CONCLUSIONS: Antiemetic treatments with a higher economical save as first-line antiemetic therapy is that using Ondansetron, and in second line the scheme using Granisetron
Subject(s)
Humans , Antineoplastic Agents/adverse effects , Antiemetics/therapeutic use , Granisetron/economics , Ondansetron/economics , Drug Costs/statistics & numerical dataABSTRACT
In a prospective randomized double-blind study, we compared the effectiveness of dexamethasone 8 mg with either granisetron 1 mg or ondansetron 4 mg in the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgery. Hundred ASA I and II patients scheduled for laparoscopic surgery were enrolled in the study and 84 patients completed it. Following induction of anesthesia, group I [n = 42] received granisetron 1 mg and dexamethasone 8 mg, group II [n = 42] received ondansetron 4 mg and dexamethasone 8 mg. Nausea and vomiting episodes, pain scores as well as side effects were recorded during the first hour and subsequently during the first 6 and 24 hours postoperatively. Satisfaction scores were obtained at discharge. There was no statistically significant difference between the 2 groups during the 1[st] 24 hours following surgery in regards to pain scores, satisfaction and side effects manifestations. At 0-1 hour interval, 100% of patients in group I and 97.6% in group II had no vomiting. Total response [no moderate or severe nausea and no rescue antiemetics] was 83.3% in group I and 80.95% in group II, and metoclopramide was used in 7.1% of patients in both groups. At 1-6 hours interval, 97.6% of patients in group I and 100% in group II had no vomiting. Total response was 92.8% in group I and 90.9% in group II, and metoclopramide was used in 4.76% of patients in group I and 2.38% in group II. At 6-24 hours no vomiting occurred in 97.6% of patients in group I and 100% in group II. Total response was 95.2% in both groups, and metoclopramide was used in 2.38% of patients in both groups. In conclusion, the combination of dexamethasone 8 mg with either granisetron 1 mg or ondansetron 4 mg following induction of anesthesia in patients undergoing laparoscopic surgery showed no statistically significant difference in antiemetic efficacy with minimal side effects and excellent patient satisfaction
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Laparoscopy , Dexamethasone , Granisetron , Ondansetron , Double-Blind Method , Prospective Studies , Treatment OutcomeABSTRACT
Pediatric strabismus surgery is commonly associated with higher incidence of postoperative nausea and vomiting [PONV]. Mixture of different classes of antiemetics have been used successfully to decrease the incidence of PONV but there was no agreement on the optimal combination. The aim of this study was to investigate the effect of granisetron, ondansetron, midazolam combination with dexamethasone in the prevention of PONV following strabismus repair in pediatric population. Healthy 100 children ASA class I and II aged 4-12 years, scheduled for elective strabismus surgery, were enrolled in this study. No premedications were given anesthesia was induced by inhalational techniques using sevoflurane, nitrous oxide and oxygen mixture. After induction, fentanyl and atracurium were given and an endotracheal tube was inserted. Patients were randomly divided into four groups which received intravenously either: Placebo, or a combination of granisetron 10 micro g/kg[-1], ondansetron 50 micro g/kg[-1], midazolam 50 micro g/kg[-1], plus dexamethasone 0.5 mg/kg [-1] after induction of anesthesia and before start of surgery. All episodes of PONV during the first 24 hours anesthesia were recorded. The incidence of postoperative nausea was 48%, 8%, 12% and 0% while the incidence of vomiting was 52%, 12%, 4% and 0% in placebo, granisetron, ondansetron, midazolam and dexamethasone combination groups respectively. No difference was detected between combination groups [P value >0.05]. Prophylactic administration of either of either granisetron, ondansetron, midazolam combined with dexamethasone markedly decreases the incidence of PONV following strabismus surgery in pediatrics. All combinations are equally effective