Reversal of Remimazolam by a Single Dose of Flumazenil

Remimazolam, a brand-new sedative which has benzodiazepine property. It is an ultra-short acting sedative and regarded as a proper drug for procedural sedation.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Flumazenil Adverse Reaction Ambulatory Surgery Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea Postoperative Nausea and Vomiting Remimazolam Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Konkuk University Medical Center

Seoul, Seoul-T'ǔkpyǒlshi, 05030, South Korea

About this study

As ambulatory surgery has been increased last two decades, 'Enhanced Recovery After Surgery (ERAS)' also has become an important issue in clinical fields.

It is very critical that managing postoperative pain, postoperative nausea and vomiting (PONV) and rapid recovery with less complication or side effect to anesthesiologists.

Even though remimazolam considered as an ultra-short acting sedative, it shows a relatively longer recovery time than propofol. Fortunately, remimazolam has its own antidote, called 'flimazenil'. With flumazenil, the time to recovery of consciousness dramatically reduces.

Common side effects of flumazenil include headache, dizziness, nausea, vomiting, flushing, sweating and injection pain.

In this trial we would like to demonstrate that routine single dose of flumazenil could be administered as an antidote of remimazolam without complications or side effects in gynecologic ambulatory surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

participants aged over 20 years scheduled for ambulatory gynecologic surgery.

Exclusion criteria

allergy or hypersensitivity to flumazenil, benzodiazepines, NSAIDs, 5-HT3
arrhythmia, myocardial infarction, coronary artery disease
obstructive sleep apnea
severe or acute respiratory distress
tricyclic anti-depressant
lactose intolerance
BMI over 30kg/m2
ASA classification 4 or 5

Treatment and study plan

Flumazenil

Drug

During the procedure, continuous infusion of remimazolam dose of 2mg/kg/hr. when procedure ends, infusion remimazolam stops and 0.9% normal saline or 0.2mg of flumazenil according to allocated groups.

Other names: placebo

Primary outcomes

the incidence of postoperative nausea and vomiting (PONV)

Time frame: up to 24 hours after participants discharge from day surgery center.

assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: May 19, 2022
Registry last updated: May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting