A Randomized, Single-Blind, Investigator Initiative Trial Study of Remimazolam Versus Midazolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Samsung Medical Center1 site in 1 country132 target enrollmentApril 5, 2023

ConditionsHealthy

InterventionsMidazolam Remimazolam

DrugsRemimazolam Midazolam

Overview

Phase: Phase 3
Intervention: Midazolam
Conditions: Healthy
Sponsor: Samsung Medical Center
Enrollment: 132
Locations: 1
Primary Endpoint: Total procedure time
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are:

Superiority of total procedure time in remimazolam compared to midazolam
The success of sedation time

This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group

Registry

clinicaltrials.gov

Start Date

April 5, 2023

End Date

January 6, 2024

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who agreed for this clinical trials
•Patients who want diagnostic endoscopy under sedation
•The total procedure time which is predicted within 15 minutes
•BMI more than 18.5kg/m2, less than 30kg/m2

Exclusion Criteria

•Patients who have stomach illness
•Patients with respiratory disease
•Mallampati Score\>=3
•Systolic BP \>160mmHg or \<90mmHg
•Refractory Hypertension
•Uncontrolled glaucoma
•Severe liver failure or chronic kidney disease
•Patients with drug abuse or alcohol abuse within 1 year
•Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam)
•Obstructive sleep dyspnea patients

Arms & Interventions

Midazolam

The patient with midazolam

Intervention: Midazolam

Remimazolam

The patient with remimazolam

Intervention: Remimazolam

Outcomes

Primary Outcomes

Total procedure time

Time Frame: begin when the drug is give to when the endoscopy is withdrawn

Secondary Outcomes

The success rate of sedation(Completion of the whole endoscopy procedures, No requirement for an alternative and/or rescue sedative, Administered up to a maximum of five supplemental doses within 15 mnutes after the initial dose)