Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

NCT05836545 | Completed Phase 3 DMC

• 1 other identifier: 2022-08-2391
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Total procedure time

  begin when the drug is give to when the endoscopy is withdrawn

Secondary Outcomes (1)

• 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

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

The patient with midazolam

Drug: Midazolam

Remimazolam

EXPERIMENTAL

The patient with remimazolam

Drug: Remimazolam

Interventions

Remimazolam DRUG

The patient with remimazolam

Remimazolam

Midazolam DRUG

The patient with midazolam

Midazolam

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Park Y, Lee JK, Lee KH, Kim T, Kang SH, Ahn DW, Kim SB, Kim SJ. Remimazolam Enables Faster Sedation Induction and Recovery Compared With Midazolam in Diagnostic Upper Gastrointestinal Endoscopy: A Multicenter Randomized Controlled Trial. United European Gastroenterol J. 2026 Feb;14(1):e70147. doi: 10.1002/ueg2.70147. Epub 2025 Nov 24.

  PMID: 41284133 DERIVED

MeSH Terms

Interventions

remimazolam; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Taejun Kim

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: April 5, 2023
• Primary Completion: January 6, 2024
• Study Completion: January 6, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

KR (1)