Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Samsung Medical Center132 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

132

Conditions

Healthy

Interventions

RemimazolamDRUG

The patient with remimazolam

MidazolamDRUG

The patient with midazolam

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Total procedure time

Time frame: begin when the drug is give to when the endoscopy is withdrawn

Secondary Outcomes

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

Data from ClinicalTrials.gov

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