Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapy-induced nausea and vomiting: A triple-blinded randomized clinical trial

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.

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

A Comparable Study on Efficacy of Granisetron and Promethazine in Controlling Hyperemesis Gravidarum

Purpose: Hyperemesis gravidarum is one of the leading causes of hospitalization during pregnancy. This randomized study wasaimed to compare and evaluate the efficacy of granisetron and promethazine in controlling nausea and vomiting in pregnancy.Materials and Methods: This study was done in the Department of Obstetrics and Gynaecology, Nalanda Medical College andHospital, Patna, Bihar, over a period of 6 months from February 2019 to July 2019. The included patients were administeredgranisetron and promethazine randomly and evaluated for nausea and vomiting by senior gynecologist blinded to designated drugs.Results: This study showed that granisetron was more effective than promethazine in controlling nausea and vomiting inpregnant patients. Greater patient satisfaction and less adverse drug reaction were observed in women receiving granisetron.Conclusion: Hyperemesis gravidarum is a health-related problem with social, economic, and psychological dimensions.All efforts, especially simple outpatient strategies, can reduce the severity of this condition and will help pregnant women tocontinue her pregnancy with satisfaction.

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.

A Prospective And Randomized Double Blind Study To Compare The Effectiveness Of Prophylactic Granisetron Versus Pethidine For The Prevention Of Postoperative Shivering In Patients Undergoing Elective Thyroid Surgeries

MATERIALS AND METHODS 90 Patients randomly allocated into three groups- qroup P, qroup G, qroup S in each group 30patientswere Selected Group P Patients were given Inj Pethidine 25 mg intravenously 5 minutes before induction of general anaesthesia. Group G Patients were given Inj Granisetron 40 microgram /Kgintravenously 5 minutes before induction of general anaesthesia. Group S Patients were given Saline intravenously 5 minutes before induction of general anaesthesia. RESULTS Postoperative shivering graded after extubation at 15 and 30 minutes interval no shivering in Pethidine group 83.3% {n= 25} Granisetron, qroup 73% {n=22} Placebo qroup 27% {n=8} P value not significant between P & G group but significant in Placebo qroup {P <0.05}. shivering occurs at grade 3in pethidine group 7% [n=2] Granisetron group 10%[n=3], Placebo group 60%[n=18] P value statistically not significant between P & G groups but significant in Placebo qroup {P <0.05}. CONCLUSION From this study prophylactic use of both Pethidine and Granisetron were equally effective for the prevention of postoperative shivering

Comparison of granisetron and lidocaine on reducing injection pain of etomidate: a controlled randomized study / Comparação de granisetrona e lidocaína na redução da dor causada pela injeção de etomidato: estudo randômico e controlado

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.

Comparative Efficacy of Ondansetron Versus Granisetron to Prevent Perioperative Nausea and Vomiting in Patients undergoing Gynaecological Surgery under Spinal Anaesthesia

Posotoprative nausea and vomiting remains a persistent and distressing problem inspite of many advances on perioperative care and anti-emetic drugs. A newer antiemetic drug Granisetron has not been studied in patients undergoing gynaecological surgery under spinal anaesthesia

Comparative Study Of Efficacy Of Palonosetron With Dexamethasone Versus Granisetron With Dexamethosone In Laproscopic Abdominal Surgeries For Control Of Post Operative Nausea And Vomiting.

Background & Aim: This study was carried out to demonstrate the efficacy and compare a dose of Granisetron with Dexamethasone and Palonosetron with Dexamethasone for prophylaxis against postoperative nausea and vomiting. Aim is to study the effectiveness of palonosetron and granisetron with aims of evaluating the efficacy of palonosetron and granisetron with dexamethasone in prevention of postoperative nausea and vomiting and to study associated adverse effects. The study was carried out in Civil Hospital, Ahmedabad with prior permission of ethical committee of the hospital. Methodology: This study was designed to evaluate the efficacy and compare a dose of study drugs in 60 patients of either sex and age ranging from 18 to 60 years and physical status ASA risk I or II undergoing general anaesthesia for various laparoscopic surgical procedures. Patients were divided into 2 groups(n=30), assigned to receive granisetron 1mg plus dexamethasone 8mg i.v and palonosetron 0.075mg plus dexamethasone 8mg i.v. A standard general anaesthesia technique and post operative analgesia were used throughout our study. The groups were compared with regards to the incidence of complete response, mean PONV score, mean nausea VDS scores and requirement of rescue anti emetics drug at various intervals (0-6,6-24,24-72hrs). Differences in continuous variables (age and duration of anaesthesia) across two dosage groups were compared using analysis of variance (ANOVA) test which is a parametric statistical test. Differences in categorical variables (gender, presence of complete response, use of rescue anti-emetics) across two dosage groups were compared using chi square test. Differences in ordinal variables (PONV scores and 4-point verbal descriptive nausea scores) across two dosage groups were compared using non-parametric Kruskal Wallis one-way analysis of variance. Mann Whitney U test was used to conduct sub-group analyses for comparing PONV scores and 4-point verbal descriptive nausea scale scores between two given groups. McNemar's test was done to compare differences in rates of complete response in a given dosage group across different time periods of assessment. Results: Our study results shows clear superiority of palonosetron with dexamethasone as a prophylactic drug for the prevention of PONV than that of granisetron with dexamethasone. Conclusions: Due to its longer duration of action, a single dose of palonosetron with dexamethasone before induction is effective in preventing PONV for upto 72 hours and hence can be termed as a prophylactic drug for PDNV also. It’s optimal and effective dose is 0.075mg i.v. with minimal side effects.

Dexamethasone combined with other anti-emetics for prophylaxis after laparoscopic cholecystectomy

Background: Following surgery and anesthesia, post-operative nausea and vomiting (PONV) are two of the most common side effects. Dexamethasone has been reported to be effective in reducing the incidence of emesis in patients undergoing chemotherapy. Aim: The aim of the study was to compare the effectiveness of granisetron and dexamethasone in combination with ondansetron and dexamethasone in combination for prophylaxis after laparoscopic cholecystectomy. Materials and methods: This is a prospective study on patients undergoing laparoscopic cholecystectomy consisted of 200 patients. 164 patients completed the study. 82 patients in group 1 and 82 patients in group 2. Patients were randomised in two groups, namely group 1 received granisetron and dexamethasone while group 2 received ondansetron and dexamethasone. Results: Out of 200 patients who initially signed the informed consent form, 164 patients (82 in group 1 and 82 in group 2) completed the study. In this study, Granisetron + Dexamethasone was found to be as effective as when compared to ondansetron + Dexamethasone as at 0-1 hour, 100% of patients in group 1 had no vomiting and 97.56% of patients had no vomiting in group 2. Total response was present in 97.56% in group 1 and 95.12% in group 2. The percentage of patients who received metoclopramide was 8.53% in both the groups. At 1-7 hour, 97.56% of patients in group 1 had no vomiting and 100% of patients had no vomiting in group 2. Total response was present in 96.34% in group 1 and 93.90% in group 2. The percentage of patients who received metoclopramide was 4.87% in group 1 and 2.43% in group 2. At 7-24 hour, 97.56% of patients in group 1 had no vomiting and 100% of patients had no vomiting in group 2. Total response was present in 95.12% in group 1 and 95.12% in group 2. The percentage of patients who received metoclopramide was 2.43% T. Uma Maheswara Rao. Dexamethasone combined with other anti-emetics for prophylaxis after laparoscopic cholecystectomy. IAIM, 2016; 3(6): 136-141. Page 137 in both the groups. 4 out of 82 patients complained of dizziness in group 1 and 4 out of 82 patients complained of dizziness in group 2. 6 out of 82 patients complained of headache in group 1 and 6 out of 82 patients complained of headache in group 2 in the post anaesthesia care unit. Pain scores in group 1 were at 0-1 hr was 6±2.4, at 1-7 hour was 5.4±0.7 and at 7-24 hour was 3.5±0.9. Pain scores in group 1 were at 0-1 hr was 7±2.3, at 1-7 hour was 5.9±2.7 and at 7-24 hour was 4.5±0.2. In between the two groups, there was no significant difference in the side effects and pain scores. Conclusion: The combination of dexamethasone with either granisetron or ondansetron after induction of anesthesia in patients undergoing laparoscopic surgery showed no statistically significant difference in antiemetic efficacy with minimal side effects and excellent patient satisfaction.

Comparison of ondansetron and granisetron for antiemetic prophylaxis in maxillofacial surgery patients receiving general anesthesia: a prospective, randomised, and double blind study

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.

Effect of granisetron in treatment of postoperative severe vomiting after posterior scleral reinforcement / 中国生化药物杂志

Objective To study curative efficacy of granisetron in treatment of postoperative severe vomiting after posterior scleral reinforcement . Methods 84 patients of posterior scleral reinforcement who received therapy from January 2012 to December 2014 in our hospital were selected as research objects.According to random number table,those patients were divided into the control group (n=100) and the observation group (n=100), the control group were treated with ondansetron hydrochloride at the end of surgery, while the observation group were treated with granisetron at the end of surgery.Then postoperative sedation, analgesia, nausea, vomiting and so on.were compared.Results There were no significant differences in anesthesia time, operation time and remifentanil dosage between the two groups.The Ramsay scores of the observation group were (2.49 ±0.31), (2.23 ±0.34) and (2.10 ±0.28) points at 30 min, 1h and 2h after operation, respectively.In the control group, Ramsay scores were (3.02 ±0.42), (2.84 ±0.37), (2.45 ±0.34) at 30 min, 1h and 2h after operation, lower than the control group.The incidence of nausea and vomiting in the observation group were 9.52% ( 4/32 ) , 11.90% ( 5/42 ) respectively, and there was no significant difference between the two groups in the postoperative analgesia The total incidence of postoperative nausea and vomiting was 30.95% (13/42) and 30.95% (13/42) respectively, which were lower than the control group (P <0.05).Conclusion Granisetron is well for postoperative posterior scleral reinforcement, which can reduce the incidence of postoperative severe vomiting, it’s worthy of application and promotion.

Nasal Mucoadhesive In-Situ Gel of Granisetron Hydrochloride using Natural Polymers.

The prolonged residence of drug formulation in the nasal cavity is of utmost importance for intranasal delivery of drug. Present investigation was aimed to develop a mucoadhesive in situ gel of Granisetron hydrochloride (GH) with reduced nasal mucocilliary clearance in order to improve the bioavailability of the antiemetic drug, granisetron hydrochloride. The in situ gelation upon contact with nasal mucosa was conferred via the use of the thermogelling Pluronic flake 127 (PF 127). Moringa gum (MG), carboxymethyl tamarind gum (CMTG) and sodium alginate (SA) was used to modulate mucoadhesion whereas drug release of optimized formulation was modified by 0.3% polyethylene glycol 6000 (PEG 6000). Results revealed that as the concentration of mucoadhesive polymer increased the mucoadhesive strength increased and gelation temperature decreased significantly. Preformulation studies showed that addition of GH in 18% PF 127 gels modulated gelation temperature significantly while mucoadhesive polymers alters mucoadhesion. Formulation F6, F11 and F15 showed more than 80% of drug diffusion at 240 min. Gelation temperature and mucoadhesive strength of all three formulations were found in the range of 30-31 C and 963.66±9.60 to 991.33±10.26 dyne/cm2 respectively. Formulation F11 showed optimum results and further histopathological evaluation reveled formulation is safe for use. Addition of PEG 6000 increased drug diffusion in formulation F11 with flux 0.034 mg.cm2/min. This study concluded the potential use of CMTG as mucoadhesive in situ nasal gel in terms of ease of administration, accuracy of dosing, prolonged nasal residence and improved nasal bioavailability.

Formulation and evaluation of taste mask pellets of granisetron hydrochloride as oro dispersible tablet

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.

The prophylactic effect of methylprednisolone combined with granisetron on postoperative nausea and vomiting after lumpectomy of breast / 临床麻醉学杂志

Objective To explore the prophylactic effect of methylprednisolone combined with granisetron on postoperative nausea and vomiting.Methods Two hundred patients scheduled for lumpectomy of breast were randomly divided into four groups with 50 cases each.The patients in group M1 received a pre-anesthesia intravenous doses of methylprednisolone 25 mg,the patients in group M2 were injected methylpredsisolone 25 mg repeatedly four hours later,in group D received a pre-anesthesia doses of dexamethasone 5 mg,in group N normal saline 2 ml.All the four groups of patients received granisetron 3 mg intravenously at the end of surgery.The incidence of nausea and vomiting in the 24 hours were observed.Results The PONV incidences of group M1,M2,D,N were 36%,18%,38% and 58%.Both group M1,M2 and D significantly decreased the total inci-dence of PONV (P <0.05)in the 24 h.The incidence of PONV was significantly lower in group M2, compared with group M1 and group D respectively (P <0.05).Conclusion Methylprednisolone-gran-isetron combination is as equally effective as dexamethasone-granisetron combination for preventing PONV in lumpectomy,but repeated methylprednisolone after 4 h is more effective than dexametha-sone and single-used methylprednisolone.

Palonosetron versus granisetron in combination with aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with gynecologic cancer / 부인종양

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.

Effects of electroacupuncture on chemotherapy-induced nausea and vomiting / 国际中医中药杂志

Objective To investigate the effects of electroacupuncture at Neiguan point (PC6) and Jianshi point (PC5) combined with granisetron on chemotherapy-induced nausea and vomiting. Methods Seventy-two tumor patients undergoing chemotherapy were randomly divided into an electroacupuncture group (38 patients) and a false electroacupuncture group (34 patients). The electroacupuncture group received electroacupuncture at PC6 and PC5 (1 h, bid) combined with granisetron (3 mg, i.v.) 30 min before chemotherapy, and repeat one time after 12 h. The false electroacupuncture group received electroacupunctur at false PC6 and false PC5, and other treatment same as the electroacupuncture group. Both groups were treated for 3 days. The nausea and vomiting frequencies and clinical effects were compared between the two groups. Results The vomiting frequency in the electroacupuncture group was significantly lower than that in the false electroacupuncture group on day 2 (0.37 ± 0.75 vs. 1.12 ± 2.13;t=2.034, P=0.046). The nausea degree in the electroacupuncture group was significantly lower than that in the false electroacupuncture group on day 2 (1.21 ± 0.93 vs. 1.88 ± 0.59;t=3.596, P=0.001) and day 3 (1.26 ± 0.92 vs. 1.68 ± 0.53; t=2.293, P=0.025). The total effective rate in the electroacupuncture group was significantly higher than those in the false electroacupuncture group on day 2 (76.3% vs. 64.7%; χ2=12.390, P=0.006) and day 3 (73.7%vs. 64.7%;χ2=12.313, P=0.006). Conclusions Electroacupuncture at PC6 and PC5 combined with granisetron can attenuate chemotherapy-induced nausea and vomiting.

Effect of palonosetron in preventing chemotherapy-induced vomiting / 中国肿瘤临床

Objective:To evaluate the efficacy and safety of palonosetron in preventing chemotherapy-induced vomiting. Meth-ods:A multi-center, randomized, double-blind, and self-cross-over positively controlled clinical trial design was used. All patients were randomized into two groups, as follows:Regiment A (61 cases) and Regiment B (64 cases). Regimen A with palonosetron hydrochlo-ride injection (test agent) was used in the treatment cycle A, whereas granisetron hydrochloride injection (control drug) was used in the cycle B. Treatments were randomly administered on the patients of the two groups. Regimen B was on the contrary, the control drug was used in the cycle A, and the test agent was used in the treatment cycle B. All patients treated with the test agent were classified as the test group, whereas those treated with the control drug were classified as the control group. Complete control rate and adverse reac-tion of acute and delayed vomiting in the two groups during the two cycles of chemotherapy regimen were compared. Results: In Group One, the complete control rate of delayed vomiting was significantly higher in the palonosetron administration cycles than in the granisetron cycles (76.92%vs. 55.38%, P=0.0110). In the same group, the frequency of vomiting was significantly less in palonosetron cycles than in the granisetron cycles during day 1 to day 5 (1.32±3.42 vs. 1.94±3.03, P=0.0096). The incidences of adverse effects were low in both groups. No grades 3 and 4 adverse effects were observed. Conclusion: Palonosetron showed efficacy in preventing the acute and delayed chemotherapy-induced vomiting. The drug is superior to granisetron, specifically in delaying vomiting in Group One. Palonosetron hydrochloride showed slight adverse effects. Hence, this drug can be used in clinic.

Stability-indicating HPLC-DAD method for the determination of Granisetron hydrochloride in its pharmaceutical preparations.

A selective and reproducible high performance liquid chromatographic method has been developed for the determination of granisetron hydrochloride in presence of its hydrolytic, oxidation, photodecomposition and thermal degradation products. Successful separation of granisetron from its degradation products is achieved on X-Bridge C18 column using acetonitrile: 0.025 M KH2PO4 solution (20:80) adjusted to pH 2 as mobile phase. The method is selective for the determination of granisetron hydrochloride, benzyl alcohol (preservative) and sodium benzoate (preservative) in presence of benzaldehyde; the oxidation product of benzyl alcohol. The method is validated and validation acceptance criteria are met in all cases. Recovery experiments of granisetron hydrochloride, benzyl alcohol and sodium benzoate from a mixture of ICH stress-formed degradation products and benzaldehyde are between 99.5-100.5% with RSD% values less than 1.5%. The proposed validated stability-indicating method is applied to the determination of granisetron and the co-formulated preservatives in tablets, oral solution and injections.

A comparative study of the effect of ondansetron, granisetron and alprazolam on anxiety in wistar rats.

Objective: The study was undertaken to compare the effect of ondansetron, granisetron and alprazolam on anxiety in rats. Materials and Methods: Elevated plus maze and Open field test were used to compare the effect of drugs on anxiety in rats. Six groups of rats were treated with 2% gum acacia orally, alprazolam 0.08mg/kg body weight of the rat orally, ondansetron (0.01mg/kg, 1mg/kg intraperitoneally) and granisetron (0.01mg/kg and 1mg/kg intraperitoneally) respectively. The time spent, number of entries and rears in the arms of the elevated plus maze and central and peripheral areas in the open field test Results: Alprazolam and ondansetron significantly increased (P<0.05) the time spent in open arm of elevated plus maze and central squares in the open field and decreased (P<0.05) the time spent in the closed arm of elevated maze and peripheral squares in the open field as compared to control. There was no significant difference between the effects of alprazolam and ondansetron. Granisetron did not produce any significant effect in any of the models. Conclusion: Ondansetron, but not granisetron, produced anxiolytic activity in rats which was comparable to alprazolam.

Formulation and evaluation of fast dissolving tablets of Granisetron hydrochloride by vacuum drying technique.

The purpose of this investigation was to develop fast dissolving tablets (FDTs) of Granisetron hydrochloride (GHCl) by vacuum drying technique using camphor as subliming agent together with croscarmellose sodium (CCS), crospovidone (CP), sodium starch glycolate (SSG) and plantago ovate (PO) as superdisintegrants. The prepared formulations were evaluated for pre-compressional and post-compressional parameters. The compatibility of drug with other ingredients was checked by FTIR studies, the results revealed that there was no interaction between dug and other excipients. The values of pre-compressional parameters were within prescribed limits and indicated good free flowing properties. In all the formulations the hardness test indicates good mechanical strength. Friability of all formulations was less than 1. Drug content was found to be high (≥ 100.44%) and uniform in all the formulations. The tablet thickness was found to be 3.11 – 3.34. The weight variation results revealed that average percentage deviation was less then ± 7.5 %, which provides good uniformity in all formulations. The disintegration time of the tablets found to be in the range of 18 to 44 sec. The formulations SBC4, SBP4, SBG4, and SBO4 50 % of drug released in 0.41, 0.48, 0.59 and 0.47 min, and 90 % of drug released in 2.01, 3.05, 4.01 and 2.51min. Stability study carried out as per ICH guidelines for three months and results revealed that upon storage disintegration time of tablets decreased significantly (p<0.05). The release of drug from the SBC4 and SBO4 formulations was quick when compared to other formulations. It was concluded that fast dissolving tablets with improved Granisetron hydrochloride dissolution could be prepared by sublimation of tablets containing suitable subliming agent.