CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 130 enrolled
Drug / intervention
Metoclopramide +3 moredrug
Likely dose
Metoclopramide 0.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05087615
NCT05087615Phase 3Completed

Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery: a Randomized Clinical Trial

Shahid Beheshti University of Medical Sciences·interventional·Posted Oct 21, 2021·Updated Oct 29, 2021

In Brief

A Phase 3 clinical trial evaluating Metoclopramide, Ondansetron, and 2 other interventions for Bariatric Surgery Candidate and 4 related conditions. Completed, enrolled 130 participants across 1 site.

Detailed Summary

Post-operative nausea and vomiting (PONV) is one of the leading causes of patient morbidity after laparoscopic bariatric surgeries. A wide variety of complications related to PONV has been described, such as prolonged length of stay (LOS) in hospital, unnecessary readmissions, delay in oral intake, and bad experience for patients. Although several antiemetic regimens have been tried so far in different studies, the incidence of PONV is not significantly lowered, and it seems that it is impossible to totally eliminate it. On the other hand, the implementation of Enhanced Recovery After Surgery (ERAS) has greatly reduced the incidence of PONV and LOS. Therefore, a combination of ERAS and multiple antiemetic regimens is currently used to reduce the incidence of PONV. Nevertheless, the optimal regimen has not been found yet, and many trials are conducting to find out the best antiemetic regimen. In this randomized clinical trial, we compare four different combined and single regimens alongside the implementation of ERAS to show which regimen is more effective.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIran
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 21, 2021
Enrollment StartMar 1, 2021
Primary CompletionAug 21, 2021
Study CompletionSep 6, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.7 years ago

Interventions

Metoclopramidedrug

This groups only received metoclopramide 0.2 mg/kg IV Bid as antiemetic in the postoperative period.

Ondansetrondrug

This groups only received ondansetron 8 mg IV Bid as antiemetic in the postoperative period.

Metoclopramide and Ondanterondrug

This groups received both metoclopramide 0.2 mg IV Bid and ondansetron 8 mg IV/Bid as antiemetics in the postoperative period.

Granisetrondrug

This groups only received granisetron 2 mg IV Bid as antiemetic in the postoperative period.