CompletedPhase 3

Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

South Korea132 participantsStarted 2023-04-05

Plain-language 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

Who can participate

Age range18 Years – 60 Years

SexALL

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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

What they're measuring

Total procedure time

Timeframe: begin when the drug is give to when the endoscopy is withdrawn

Trial details

NCT IDNCT05836545

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-06

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