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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Interventional
• Participants enrolled: 60
• From 23 Aug 2023 to the primary completion date, 1 Dec 2023
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.