Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Midazolam

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

• 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