Reversal of Remimazolam by a Single Dose of Flumazenil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2023-05-13

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.

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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.

Conditions

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Flumazenil Adverse Reaction Ambulatory Surgery Postoperative Nausea Remimazolam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

participants and outcome assessors are blinded to which group participants are allocated.

Study Groups

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group Control

participants are administered 2mL of 0.9% placebo at the end of procedure.

Group Type PLACEBO_COMPARATOR

Flumazenil

Intervention Type 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.

group Flumazenil

participants are administered 0.2mg (2mL) of flumazenil at the end of procedure.

Group Type ACTIVE_COMPARATOR

Flumazenil

Intervention Type 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.

Interventions

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Flumazenil

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.

Intervention Type DRUG

Other Intervention Names

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placebo

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

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes