Reversal of Remimazolam by a Single Dose of Flumazenil

Konkuk University Medical Center

Status: Completed

Conditions: Remimazolam; Ambulatory Surgery; Flumazenil Adverse Reaction; Postoperative Nausea

Treatments: Drug: Flumazenil

Study type: Interventional

Funder types: Other

Identifiers

NCT05382806

KUMC2021-11-058

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 224 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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224 participants in 2 patient groups, including a placebo group

group Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Flumazenil

group Flumazenil

Active Comparator group

Description:

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

Treatment:

Drug: Flumazenil