Reversal of Remimazolam by a Single Dose of Flumazenil

Not Applicable

Completed

• Conditions: Flumazenil Adverse Reaction; Ambulatory Surgery; Postoperative Nausea; Remimazolam
• Interventions: Drug: Flumazenil

• Registration Number: NCT05382806
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-19
• Study Start: 2022-08-02
• Status Verified: 2023-05
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-13
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group Control	Flumazenil	participants are administered 2mL of 0.9% placebo at the end of procedure.
group Flumazenil	Flumazenil	participants are administered 0.2mg (2mL) of flumazenil at the end of procedure.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Seoul-T'ǔkpyǒlshi, Korea, Republic of