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 Granisetron versus Granisetron-Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Pediatric Strabismus Surgery: A Randomized Double-Blind Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Renu Sinha ◽  
Dilip Shende ◽  
Souvik Maitra ◽  
Neeraj Kumar ◽  
Bikash Ranjan Ray ◽  
...  
Keyword(s):  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Strabismus Surgery ◽  
Nausea And Vomiting ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Oculocardiac Reflex ◽  
Significant Difference

Aim.Efficacy of granisetron and combination of granisetron and dexamethasone was evaluated for prevention of postoperative nausea and vomiting (PONV) in children undergoing elective strabismus surgery.Methods.A total of 136 children (1–15 years) were included. Children received either granisetron (40 mcg/kg) [group G] or combination of granisetron (40 mcg/kg) and dexamethasone (150 mcg/kg) [group GD]. Intraoperative fentanyl requirement and incidence and severity of oculocardiac reflex were assessed. PONV severity was assessed for first 24 hours and if score was >2, it was treated with metoclopramide. Postoperative analgesia was administered with intravenous fentanyl and ibuprofen.Results.The demographic profile, muscles operated, and fentanyl requirement were comparable. Complete response to PONV in first 24 hours was observed in 75% (51/68) of children in group G and 76.9% (50/65) of children in group GD, which was comparable statistically (p=0.96, Fisher exact test; OR 1.11, 95% CI 0.50, 2.46). Incidence of PONV between 0 and 24 hours was comparable. One child in group G required rescue antiemetic in first 24 hours and none of the children had severe PONV in group GD. There was no significant difference in incidence or severity of oculocardiac reflex.Conclusion.Dexamethasone did not increase efficacy of granisetron for prevention of PONV in elective pediatric strabismus surgery. Registration number of clinical trial wasCTRI/2009/091/001000.

scholarly journals Addition of Dexamethasone to Prophylactic Granisetron in Children Undergoing Ocular Surgeries – A Randomised Controlled Double-Blind Trial

2021 ◽  
Vol 8 (01) ◽  
pp. 12-16
Author(s):  
Koilada Shiv Kumar ◽  
Rajan Anand ◽  
Debasis Bagchi
Keyword(s):  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Paediatric Age ◽  
Randomised Controlled ◽  
Post Operative Nausea

BACKGROUND Postoperative nausea and vomiting are highly prevalent after ophthalmic surgeries in the paediatric age group. In this randomised, double-blind prospective clinical trial, we studied and compared the efficacy of granisetron and combination of granisetron with dexamethasone to prevent postoperative nausea and vomiting after paediatric ocular surgeries. METHODS Sixty paediatric patients (06 - 12 yrs. of age) undergoing elective ocular surgeries were randomly allocated to one of the two groups of 30 patients each. Group (G) received granisetron 40 mcg kg–1 intravenously as a bolus before induction of anaesthesia. Group (G + d) received granisetron 40 mcg kg–1 & dexamethasone 0.1 mg kg–1 intravenously as a bolus before induction. Student t-test, Fisher exact test were used wherever applicable for statistical analysis using SPSS version 15.0. RESULTS A complete response (defined as no post-operative nausea and vomiting and no need for another rescue antiemetic) was achieved in 63.3 % of patients who received granisetron alone and in 96.7 % of patients who received granisetron plus dexamethasone. We found nil difference in complications between the two groups. CONCLUSIONS We found that addition of dexamethasone to granisetron is more effective and beneficial than granisetron alone in preventing postoperative emesis in 1st 24 hours. KEYWORDS Post-Operative Nausea and Vomiting, Anaesthesia, Granisetron, Dexamethasone

A RANDOMIZED, DOUBLE-BLIND STUDY OF PALONOSETRON COMPARED WITH ONDANSETRON IN PREVENTING POSTOPERATIVE NAUSEA AND VOMITING AFTER MODIFIED RADICAL MASTECTOMY SURGERY.

2021 ◽  
pp. 72-74
Author(s):  
Anusha K ◽  
Sherin bright
Keyword(s):  
Side Effects ◽  
Postoperative Nausea ◽  
Radical Mastectomy ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Post Operative Nausea

BACKGROUND : Palonosetron is a new potent 5-hydroxytryptamine 3 antagonist. Although used for chemo induced emesis, data is lacking for PONV. The high incidence of nausea and vomiting after breast surgery is well documented. This study compared the effects of i.v.ondansetron and palonosetron administered at the time of induction for preventing postoperative nausea and vomiting (PONV) in these high-risk patients . The aim was to compare Onda METHODS : nsetron 8 mg and Palonosetron 0.075mg administered intravenously for prevention of post operative nausea and vomiting in patients undergoing modied radical mastectomy 24 hours postoperatively, by a randomised , controlled, double blind study. 70 female non smoking patients scheduled for elective modied radical mastectomy were, allocated randomly into 2 groups . Patients received either Palonosetron 0.075mg (GROUP P ) or ondansetron 8mg ( GROUP O ) intravenously, immediately before induction of general anaesthesia. The occurence of nausea, vomiting, retching, need for rescue antiemetics and side effects were monitored for a period of 24 hours after surgery. The compete response rate and overall PONV for 0 - 24 hours were calculated. The demographic prole of the patients were comparable. The RESULTS : incidence of a complete response (no PONV, no rescue antiemetics ) during 0 - 24 hours in post operative period was signicantly high in GROUP P ( 85.7% vs 62.9%, p=0.02) than GROUP O. The incidence of nausea was signicantly low in GROUP P ( 14.3% vs 37.1%). There was no statistically signicant difference between the 2 groups in vomiting, retching, side effects and need for rescue antiemetics. Thus overall PONV was low in GROUP P (14.3% vs 37.1% p = 0.02 statistically signicant.) We conclude that Palonosetron 0.075mg was more effective for preventing PONV in patients undergoing modied radical mastectomy surgery

scholarly journals Preoperative Fasting Abbreviation and its Effects on Postoperative Nausea and Vomiting Incidence in Gynecological Surgery Patients

2020 ◽  
Vol 42 (08) ◽  
pp. 468-475
Author(s):  
Gisele Vissoci Marquini ◽  
Francisco Edes da Silva Pinheiro ◽  
Alfredo Urbano da Costa Vieira ◽  
Rogério Melo da Costa Pinto ◽  
Maria Gabriela Baumgarten Kuster Uyeda ◽  
...  
Keyword(s):  
At Risk ◽  
Postoperative Nausea ◽  
Randomized Study ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Gynecological Surgery ◽  
Preoperative Fasting ◽  
Double Blind ◽  
Significant Difference

Abstract Objective To investigate the effects of preoperative fasting abbreviation with a carbohydrate and protein-enriched solution, on postoperative nausea and vomiting (PONV) incidence in gynecological surgery patients, a population naturally at risk for such unpleasant episodes. Methods The present prospective double-blind randomized study was performed at The Hospital Municipal e Maternidade Dr. Odelmo Leão Carneiro (HMMOLC, in the Portuguese acronym), in Uberlândia, state of Minas Gerais, Brazil, in partnership with the Gynecology Department of the Universidade Federal de São Paulo (UNIFESP), approved by the Human Research Ethics Committee of UNIFESP and the board of HMMOLC, and included in the Brazil Platform and in the Brazilian Clinical Trial Registry. After signing the consent form, 80 women, who were submitted to gynecological surgery in the period from January to June 2016, were randomized into 2 groups: control group (n = 42) and juice group (n = 38). They received, respectively, 200 mL of inert solution or liquid enriched with carbohydrate and protein 4 hours presurgery. The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA). Results The incidence of nausea and vomiting was lower than in the literature, to this population, with 18.9% (14/74) for the control group and 10.8% (8/74) for the juice group, respectively, with no statistically significant difference between the groups. Conclusion The incidence of nausea and vomiting was lower than in the literature, but it cannot be said that this is due to the abbreviation of fasting. It can provide greater comfort, with the possibility of PONV prevention in patients at risk for these episodes.

Palonosetron Hydrochloride in the Prevention and Treatment of Postoperative Nausea and Vomiting

2010 ◽  
Vol 2 ◽  
pp. CMT.S4016 ◽  
Author(s):  
Jan Wallenborn ◽  
Peter Kranke
Keyword(s):  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Paediatric Population ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Pharmacokinetic Data ◽  
Qtc Interval ◽  
Two Phase ◽  
Geriatric Population

On the strength of two phase III clinical trials, palonosetron hydrochloride was granted FDA approval in March 2008 for the prevention of postoperative nausea and vomiting (PONV) in the period up to 24 hours after surgery. Palonosetron is superior to the established first-generation 5-hydroxytryptamin-3 receptor antagonists (5-HT3-RAs) in respect of pharmacokinetic data such as a high receptor binding affinity (pKi = 10.45) and a prolonged mean elimination half-life (40 hours). Clinically, palonosetron 0.075 mg was superior to placebo within the 0 to 24 h period usually investigated. A pooled data analysis of the complete response (CR) rates revealed efficacy in the 0 to 24 h period (when compared to placebo CR = 1.67 [1.38–2.02; P < 0.001, n = 370]) and between 24–72 h after surgery (CR = 1.29 [1.10–1.51; P = 0.002, n = 273]). Overall, the effect of palonosetron in reducing delayed vomiting was not as promising as expected. In the approval studies for PONV the rates of AEs including headache (3%), constipation (2%) and prolongation of the QTc interval (5%) were indistinguishable between palonosetron and placebo. In studies on chemotherapy-induced nausea and vomiting, palonosetron increased the QTc interval (between one and three ms) to a lesser extent than ondansetron or dolasetron (5 ms). The safety profile of palonosetron therefore seems to be favourable so far, making it a preferred perioperative antiemetic in the geriatric population or in multimorbid patients. However, further studies are needed to permit general recommendations, and we still lack comparative trials with older (and less expensive) 5-HT3-RAs, trials with combined PONV prophylaxis, and trials in the paediatric population.

scholarly journals Is Infusion of Subhypnotic Propofol as Effective as Dexamethasone in Prevention of Postoperative Nausea and Vomiting Related to Laparoscopic Cholecystectomy? A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Mine Celik ◽  
Aysenur Dostbil ◽  
Mehmet Aksoy ◽  
Ilker Ince ◽  
Ali Ahiskalioglu ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Postoperative Nausea ◽  
Controlled Trial ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Significant Difference ◽  
Group D

Background. Postoperative nausea and vomiting (PONV) is one of common complications in patients undergoing laparoscopic cholecystectomy (LC). Aim of this study was to compare the efficacy of subhypnotic (1 mg/kg/h) infusion of propofol with dexamethasone on PONV in patients undergoing LC.Methods. A total of 120 patients were included in this randomized, double-blind, placebo-controlled study. Patients were randomly assigned to 3 groups; patients of group dexamethasone (group D) were administrated 8 mg dexamethasone before induction of anesthesia, patients of group propofol (group P) were infused to subhypnotic (1 mg/kg/h) propofol during operation and patients of group control (group C) were applied infusion of 10% intralipid. The incidence of PONV and needs for rescue analgesic and antiemetic were recorded in the first 24 h postoperatively.Results. In the 0–24 h, the incidence of PONV was significantly lower in the group D and group P compared with the group C (37.5%, 40%, and 72.5%, resp.). There was no significant difference in the incidence of PONV and use of antiemetics and analgesic between group D and group P.Conclusion. We concluded that infusion of propofol 1 mg/kg/h is as effective as dexamethasone for the prevention of PONV during the first 24 hours after anesthesia in patients undergoing LC.

scholarly journals Effect of Supplemental Perioperative Oxygen 80% in Postoperative Nausea and Vomiting in Patients Undergoing Cataract Surgery

2019 ◽  
Author(s):  
Aliakbar Keykha ◽  
Mahshid Ashrafzadeh ◽  
Alireza Rahat Dahmardeh ◽  
Bibi Mahdie Khodadadi Hosseini
Keyword(s):  
Cataract Surgery ◽  
Incidence Rate ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Supplemental Oxygen ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference

Background: Postoperative nausea and vomiting (PONV) leads to an increase in intraocular pressure (IOP) and its side effects, which should be controlled using the least complicated method. Therefore, the purpose of this study was to evaluate the effect of 80% supplemental perioperative oxygen on PONV in patients undergoing cataract surgery. Methods: The present double-blind clinical trial was conducted on 201 patients undergoing cataract surgery. The subjects were selected by convenience sampling method and randomly divided into two groups of oxygen 30% administration and oxygen 80% administration. The operation of patients was performed with the same surgical procedure and team. After the operation, the incidence rate of PONV was recorded in both groups and compared along with other variables by SPSS software using descriptive statistics and chi-square. Results: There was no significant difference in age and sex between the two groups. The incidence rate of PONV was high in both groups, with statistically significant higher value in the group with 30% supplemental oxygen compared to the group with 80% supplemental oxygen (p=0.000). Conclusion: The use of 80% perioperative oxygen concentration could reduce the PONV severity

scholarly journals Comparison of Granisetron and Granisetron Plus Dexamethasone for the Prevention of Post-operative Nausea and Vomiting (PONV)

2007 ◽  
Vol 8 (Number 1) ◽  
pp. 21-27
Author(s):  
K S Islam ◽  
S M Bakhtiar ◽  
M A Mannan
Keyword(s):  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Combination Group ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Group B ◽  
Post Operative Nausea ◽  
Induction Of Anaesthesia

77tere is a high incidence of postoperative nausea and vomiting (PONV) in patients undergoing surer, and anaesthesia. Many factors are claimed to be responsible for POW. This stad.v MU designed to compare the effectiveness of grornsetron pits desomethasone with gran isetron alone to prevent post-operative nausea and vomiting. In this randomised double blind study. sixty patients were divided into two egnal groups ( n=30 each ). Patients in Group A received granisetron 40 pion per kg before inductor of anaesthesia and those in Group B received gmnisetron 40 pp: per kg phis devamethasone 8 nog before induction of anaesthesia. All the patients were observed for post-opera tive nausea and vaniting for 24 hours (0-6 hours in the recovety room and 18 hours in ward or cabin). A significant difference was found in complete response, defined as no pos,opertalve nausea and vomiting. between patients of graniserron alone group and those of granisetron pins dexamethasone combination group. The combination of grontsoron plus de.tainethasone is considered to be more effective for prevention of post-operative nausea and vomiting.

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