CompletedNot Applicable

Finding ED90 of Flumazenil for Selective Improvement of Respiratory Distress by Remimazolam

South Korea60 participantsStarted 2023-08-23

Plain-language summary

Patients undergoing endoscopic submucosal dissection with monitored anesthesia care (MAC) using remimazolam may develop respiratory distress during the procedure. In these cases, substandard doses of flumazenil have been found to improve respiratory distress without completely reversing sedation, a novel and previously unknown phenomenon. This study aimed to explore the ED90 of flumazenil to selectively improve only respiratory distress during MAC with remimazolam. The dose determination for flumazenil will follow a biased-coin up-and-down design. Starting with an initial dose of 5 mcg, if there is an improvement in respiratory distress, the biased-coin method will be used to administer the same dose to the next patient with a probability of 8/9, and a decreased dose of 5 mcg to the next patient with a probability of 1/9. Any improvement in respiratory distress within 30 seconds of flumazenil administration will be recorded. After the procedure, the patient will be asked if they had any memory recall of the procedure. Centered isotonic regression will be used to obtain the ED90 of flumazenil.

Who can participate

Age range

19 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: * American Society of Anesthesiologists (ASA) class I-III * 19 years of age or older * Scheduled for gastric ESD by MAC with remimazolam * Hemodynamically stable patients. Exclusion Criteria: * Patients who have airway-related anatomic abnormalities * Being requested by the endoscopist to be fully awake from anesthesia for any reason other than respiroatyr distress during the procedure * Being administered any sedative other than remimazolam during the procedure (e.g., propofol, dexmedetomidine, etc.)

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

Whether it was successful or unsuccessful to improve the patient's respiratory distress

Timeframe: 30 seconds after the intervention

Trial details

NCT IDNCT06563063

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

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