Trial intelligence / Profile preview

REST: Remimazolam vs Midazolam for Sedation in Upper GI Endoscopy

NCT06614036Phase 4

Key facts

Status: Recruiting
Start: Oct 2024
Primary completion: Dec 2025
Countries: 1
Modality: Small Molecules

Drugs: remimazolam
Conditions: Procedural sedation (PS)

Overview

Phase 4, randomised, double-blind trial of remimazolam in Procedural sedation (PS) (2 arms). Primary endpoint: Time to full alertness. Started Oct 2024; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Remimazolam
Remimazolam for sedation
Midazolam
Midazolam for sedation

Who it enrols

Adult patients scheduled for diagnostic upper GI endoscopy, excluding those with anticipated opioid use, ASA score of 4, or unresolved substance dependency.

Endpoints

Primary

Time to full alertnessup to 60 minutes post-dose

Secondary

Patient satisfaction1 day post-procedure
Post-sedation amnesia1 day post-procedure
Incidence of adverse events1 day post-procedure
Time to readiness for dischargeup to 90 minutes post-dose
Success rate of sedationup to 15 minutes post-procedure
Endoscopist satisfactionup to 15 minutes post-procedure

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