A Double-blind, Parallel-group, Placebo-controlled, Dose-ranging Study of Intravenous Granisetron in the Prevention of Postoperative Nausea and Vomiting

1994 ◽  
Vol 81 (SUPPLEMENT) ◽  
pp. A1281 ◽  
Author(s):  
P. Diemunsch ◽  
J. Wilson ◽  
K. Chitour ◽  
J. Patterson ◽  
K. L. Kong
2017 ◽  
Vol 126 (2) ◽  
pp. 268-275 ◽  
Author(s):  
Tong J. Gan ◽  
Peter Kranke ◽  
Harold S. Minkowitz ◽  
Sergio D. Bergese ◽  
Johann Motsch ◽  
...  

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.


2020 ◽  
Vol 15 ◽  
Author(s):  
Arash karimi ◽  
Jahanbakhsh Nejadi ◽  
Mahnaz Shamseh ◽  
Nooshin Ronasi ◽  
Mehdi Birjandi

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.


2019 ◽  
Vol 13 (1) ◽  
pp. 78-85
Author(s):  
Ashraf Nabil Saleh ◽  
Dalia Fahmy Emam ◽  
Mohamed Mohamed Kamal

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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