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Reversal of Remimazolam by a Single Dose of Flumazenil

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05382806
Collaborator
(none)
228
Enrollment
1
Location
2
Arms
12.9
Anticipated Duration (Months)
17.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
participants and outcome assessors are blinded to which group participants are allocated.
Primary Purpose:
Treatment
Official Title:
Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: group Control

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

Drug: 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.
Other Names:
  • placebo

    		•
    Active Comparator: group Flumazenil

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

    Drug: 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.
    Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konkuk University Medical Center Seoul Seoul-T'ǔkpyǒlshi Korea, Republic of 05030

    Sponsors and Collaborators

    • Konkuk University Medical Center

    Investigators

    • Principal Investigator: Seong-Hyop Kim, M.D. Ph.D, Konkuk University Medical Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yea-Ji Lee, Professor, Konkuk University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05382806
    Other Study ID Numbers:
    • KUMC2021-11-058
    First Posted:
    May 19, 2022
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Postoperative Nausea and Vomiting
    Flumazenil

    Study Results

    No Results Posted as of May 25, 2022