Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy (NCT05836545) | Clinical Trial Compass
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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total procedure time
Timeframe: begin when the drug is give to when the endoscopy is withdrawn