Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Phase 3

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: Midazolam; Drug: Remimazolam

• Registration Number: NCT05836545
• Lead Sponsor: Samsung Medical Center

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Study Start: 2023-05-01
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	Midazolam	The patient with midazolam
Remimazolam	Remimazolam	The patient with remimazolam

Primary Outcome Measures

Name	Time	Method
Total procedure time	begin when the drug is give to when the endoscopy is withdrawn

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of