CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 552 enrolled
Drug / intervention
Remimazolam +1 moredrug
Likely dose
Remimazolam 0.25 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/NCT04861337
NCT04861337Phase 4Completed

Effect of Remimazolam on Incidence of Postoperative Nausea and Vomiting Following General Anesthesia in High-risk Patients: a Multicenter, Double-blinded, Placebo-controlled Randomized Trial

Peking University First Hospital·interventional·Posted Apr 27, 2021·Updated Jan 3, 2024

In Brief

A Phase 4 clinical trial evaluating Remimazolam and Placebo for Postoperative Nausea and Vomiting and 2 related conditions. Completed, enrolled 552 participants across 10 sites.

Detailed Summary

This trial aims to explore whether the intraoperative use of remimazolam can reduce the incidence of postoperative nausea and vomiting (PONV) in high-risk patients. According to the Apfel's simplified score, patients with 3 or more of the following factors are at high risk of postoperative nausea and vomiting (PONV), i.e., women, non-smokers, history of PONV, and postoperative use of opioids.

Study Details

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

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedApr 27, 2021
Enrollment StartMay 19, 2021
Primary CompletionDec 31, 2022
Study CompletionApr 22, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.2 years ago

Interventions

Remimazolamdrug

Remimazolam is infused at a rate of 0.25 mg/kg/h from end of anesthesia induction until 15 minutes before the end of surgery.

Placebodrug

Normal saline is infused at a rate same as in the remimazolam group from end of anesthesia induction until 15 minutes before the end of surgery.