Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05836545

Enrollment

132

Registered

2023-05-01

Start date

2023-04-05

Completion date

2024-01-06

Last updated

2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGRemimazolam

The patient with remimazolam

DRUGMidazolam

The patient with midazolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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 * ASA \>=2 * 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 * Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption * Pregnant, breast feeding patient

Design outcomes

Primary

Measure	Time frame
Total procedure time	begin when the drug is give to when the endoscopy is withdrawn

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 13, 2026