A double-blind, parallel-group, placebo-controlled, dose-ranging, multicenter study of intravenous granisetron in the treatment of postoperative nausea and vomiting in patients undergoing surgery with general anesthesia

1997 ◽  
Vol 9 (8) ◽  
pp. 658-663 ◽  
Author(s):  
Ann M. Taylor ◽  
Michael Rosen ◽  
Pierre A. Diemunsch ◽  
Dominique Thorin ◽  
Peter L. Houweling
Keyword(s):  
General Anesthesia ◽  
Multicenter Study ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Double Blind ◽  
Parallel Group ◽  
Dose Ranging

scholarly journals Evaluation of the efficacy of Granisetron over Droperidol in the prevention of Postoperative Nausea and Vomiting following open Cholecystectomy

JMS SKIMS ◽  
2011 ◽  
Vol 14 (1) ◽  
pp. 11-14
Author(s):  
Abdul Qayoom Lone ◽  
Shruti Sharma ◽  
Mohamad Ommid ◽  
Showkat H Nengroo ◽  
Imtiyaz Naqash
Keyword(s):  
General Anesthesia ◽  
Postoperative Nausea ◽  
Open Cholecystectomy ◽  
Randomized Study ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Physical Status ◽  
Double Blind ◽  
Post Operative Nausea ◽  
To Receive

BACKGROUND: Post operative nausea and vomiting (PONV) continue to be frequent occurrences, even when conventional antiemetics are prophylactically used. OBJECTIVE: To compare the efficacy of Granisetron over Droperidol in the prevention of PONV in patients undergoing elective open cholecystectomy under general anesthesia. MATERIAL & METHODS: In this double blind randomized study, 100 adult patients with physical status ASA I and II, (age, 20-60 years), were randomly allocated into two groups, X or Y, to receive either injection Granisetron hydrochloride (3 mg i/v) or Droperidol (2.5 mg i/v), 5 min prior to induction of general anesthesia. The incidence of nausea and vomiting was recorded every six hourly for a period of 24 hour after the surgery. RESULTS: 6 (12%) patients in the granisetron group and 20 (40%) patients in the Droperidol group reported an emetic episode, (p = 0.002); the incidence of PONV in the total 24 hr period after the surgery, 54% in the granisetron group and 76% in Droperidol group (p = 0.022) CONCLUSIONS: It was found that granisetron is superior to Droperidol in the prevention of postoperative nausea and vomiting. JMS 2011;14(1):11-14

Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting

2017 ◽  
Vol 126 (2) ◽  
pp. 268-275 ◽  
Author(s):  
Tong J. Gan ◽  
Peter Kranke ◽  
Harold S. Minkowitz ◽  
Sergio D. Bergese ◽  
Johann Motsch ◽  
...  
Keyword(s):  
Postoperative Nausea ◽  
Elective Surgery ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Double Blind ◽  
Parallel Group ◽  
Significant Difference ◽  
Clinically Significant

Abstract Background Two essentially identical, randomized, double-blind, placebo-controlled, parallel-group phase III studies evaluated the efficacy of intravenous amisulpride, a dopamine D2/D3 antagonist, in the prevention of postoperative nausea and vomiting in adult surgical patients. Methods Adult inpatients undergoing elective surgery during general anesthesia and having at least two of the four Apfel risk factors for postoperative nausea and vomiting were enrolled at 9 U.S. and 10 European sites. A single 5-mg dose of amisulpride or matching placebo was given at induction of anesthesia. The primary endpoint was complete response, defined as no vomiting/retching and no use of antiemetic rescue medication in the 24-h postoperative period. Nausea incidence was a secondary endpoint. Results Across the two studies, 689 patients were randomized and dosed with study medication, of whom 626 were evaluable per protocol. In the U.S. study, 46.9% (95% CI, 39.0 to 54.9) of patients achieved complete response in the amisulpride group compared to 33.8% (95% CI, 26.2 to 42.0) in the placebo group (P = 0.026). In the European study, complete response rates were 57.4% (95% CI, 49.2 to 65.3) for amisulpride and 46.6% (95% CI, 38.8 to 54.6) for placebo (P = 0.070). Nausea occurred less often in patients who received amisulpride than those who received placebo. There was no clinically significant difference in the safety profile of amisulpride and placebo; in particular, there were no differences in terms of QT prolongation, extrapyramidal side effects, or sedation. Conclusions One of the two trials demonstrated superiority, while pooling both in a post hoc change to the plan of analysis supported the hypothesis that amisulpride was safe and superior to placebo in reducing the incidence of postoperative nausea and vomiting in a population of adult inpatients at moderate to high risk of postoperative nausea and vomiting.

scholarly journals Comparative Study of Ondansetron Versus Dexamethasone in the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia

2021 ◽  
Vol 4 (1) ◽  
pp. 81-84
Author(s):  
Sundar Prasad Hyoju
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
General Anesthesia ◽  
Postoperative Nausea ◽  
Vital Signs ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Double Blind ◽  
American Society ◽  
American Society Of Anesthesiologists

Introduction: Postoperative nausea and vomiting (PONV) have been termed as the “big little problem” for anesthesiology during laparoscopic surgery. Pain and postoperative nausea and vomiting are the most common causes of morbidity after anesthesia and surgery. We aimed to evaluate the effects of Ondansetron and Dexamethasone in preventing postoperative nausea and vomiting following laparoscopic cholecystectomy, as well as to note any pharmacological side effects that occurred after their usage. Methods: In this prospective, randomized, double blind controlled study, trial was done after approval from the IRB and trail registry, 60 female patients of American Society of Anesthesiologists physical status I and II, aged 18 to 65 years, weighing 50-60 kg, and standing 150 to 160 cm, were given institutional ethical committee clearance and written informed consent before undergoing laparoscopic cholecystectomy (duration 90 minutes) under general anesthesia. Patients arriving in the operating room were sorted into two groups of 30 patients each. All patients were monitored after surgery, documenting vital signs and any difficulties that arose. For the first 12 hours after surgery, all bouts of PONV (nausea, vomiting, and retching) were documented. Each patient's data was gathered and tallied. Results: The patients in the study group were similar in age, weight, height, ASA status, and operation duration (p 0.05), and there was no significant statistical difference between the data gathered throughout the study Conclusions: Ondansetron is just as effective as Dexamethasone at lowering nausea and vomiting after laparoscopic cholecystectomy, and it comes with less adverse effects.

Comparison of the effects of Dexamethasone and Ondansetron on the Reduction of Postoperative Nausea and Vomiting following Cesarean Section under Spinal Anesthesia

2020 ◽  
Vol 15 ◽  
Author(s):  
Arash karimi ◽  
Jahanbakhsh Nejadi ◽  
Mahnaz Shamseh ◽  
Nooshin Ronasi ◽  
Mehdi Birjandi
Keyword(s):  
Cesarean Section ◽  
Spinal Anesthesia ◽  
Postoperative Nausea ◽  
Demographic Data ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Elective Cesarean Section ◽  
Double Blind ◽  
Group A ◽  
Group B

Background: Postoperative nausea and vomiting (PONV) is a common complication associated with the use of anesthesia. Several antiemetics are used to reduce the incidence and severity of PONV. The aim of this study is to investigate the role of dexamethasone and ondansetron to treat PONV in patients undergoing cesarean section (c-section) under spinal anesthesia. Methods: This double-blind clinical trial study was performed on patients who were referred to the operating room of Haji Karim Asali Hospital of Khorramabad for elective cesarean section in 2016-17. Upon meeting the inclusion criteria, patients were allotted into two groups (n=60). Group A received 8mg of dexamethasone and group B received 4mg of ondansetron after spinal anesthesia. The Visual Analog Scale (VAS) questionnaire and Depression-Anxiety-Stress Scale (DASS) questionnaire was used for the analysis. Patients with mild to moderate stress, anxiety, and depression were included in the study. Data were analyzed using SPSS 16 software. Results: There was no difference in the demographic data of the two groups. The mean severity of nausea in group A was significantly higher than in group B. The frequency of vomiting in group A was 20 times higher than group B, which was found to be statistically significant, p = 0.018. Concerning the type of delivery with the frequency of nausea, the results showed that the frequency of nausea in group A was 3.24 times higher than group B, however, this difference was not statistically significant, p = 0.106. Conclusion: Based on the results of this study, ondansetron had a significant effect on the alleviation of postoperative nausea and vomiting, as compared to dexamethasone in c-section surgical candidates.

scholarly journals Evaluating the Effect of Intraoperative Dextrose 10% Administration on Reducing Postoperative Nausea and Vomiting after Laparoscopic Surgery

2019 ◽  
Vol 13 (1) ◽  
pp. 78-85
Author(s):  
Ashraf Nabil Saleh ◽  
Dalia Fahmy Emam ◽  
Mohamed Mohamed Kamal
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Study Groups ◽  
Primary Objective ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Double Blind ◽  
Female Patients ◽  
Medication Consumption

Background: Although PONV is usually self-limiting or is treated without sequelae, the incidence of PONV could be as high as 70% to 80% in high-risk populations such as female sex, obese patients, age younger than 40 years, nonsmoker patients, history of PONV or motion sickness. Objectives: The study aimed to investigate whether dextrose 10% decreases the incidence of postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy Materials and Methods: This prospective, double-blind randomized placebo-controlled study comprised 130 ASA physical status I and II nonsmoker female patients, 20-40 years of age, scheduled for laparoscopic cholecystectomy at Ain Sham University – Assembled operating theater from August 2018 to October 2018. Patients were arbitrarily divided into two study groups of 65 patients each. Group LR received lactated Ringer’s solution and group D received 10% dextrose. The primary objective of this study was to compare the incidence of PONV in the study treatment groups. The secondary outcomes included measurement of antiemetic medication consumption as well as blood glucose changes between groups. Results: 50 from a total of 65 participants (76.9%) in Lactated Ringer (LR) group experienced nausea. On the other hand, 30 participants only (46.2%) in dextrose (D) group were nauseated. This dissimilarity was statistically highly significant (P= 0.0003). Conclusion: In this study, dextrose 10% administration resulted in improved postoperative emesis management as explained by the lower incidence of nausea and rescue antiemetic consumption.

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