Reversal of Remimazolam by a Single Dose of Flumazenil

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Flumazenil Adverse Reaction, Ambulatory Surgery, Postoperative Nausea, Remimazolam

Intervention / Treatment
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* Drug: Flumazenil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group Control<br>participants are administered 2mL of 0.9% placebo at the end of procedure. | Drug: Flumazenil<br>* 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.<br>* Other names: placebo;|
| Active Comparator: group Flumazenil<br>participants are administered 0.2mg (2mL) of flumazenil at the end of procedure. | Drug: Flumazenil<br>* 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.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of postoperative nausea and vomiting (PONV) | assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting | up to 24 hours after participants discharge from day surgery center. |