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Completed

NCT Number: NCT05836545

Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

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

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

The patient with remimazolam

midazolam

Drug

The patient with midazolam

Primary outcomes

  1. Total procedure time

    Time frame: begin when the drug is give to when the endoscopy is withdrawn

Secondary outcomes

  1. The success rate of sedation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 1, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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