Back to resultsReversal of Remimazolam by a Single Dose of Flumazenil
Primary Purpose
Flumazenil Adverse Reaction, Ambulatory Surgery, Postoperative Nausea
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Flumazenil
Sponsored by
About this trial
This is an interventional treatment trial for Flumazenil Adverse Reaction
Eligibility Criteria
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
Sites / Locations
- Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
group Control
group Flumazenil
Arm Description
participants are administered 2mL of 0.9% placebo at the end of procedure.
participants are administered 0.2mg (2mL) of flumazenil at the end of procedure.
Outcomes
Primary Outcome Measures
the incidence of postoperative nausea and vomiting (PONV)
assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting
Secondary Outcome Measures
Full Information
NCT ID
NCT05382806
First Posted
May 11, 2022
Last Updated
May 18, 2023
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05382806
Brief Title
Reversal of Remimazolam by a Single Dose of Flumazenil
Official Title
Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 13, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flumazenil Adverse Reaction, Ambulatory Surgery, Postoperative Nausea, Remimazolam
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).
Masking
ParticipantOutcomes Assessor
Masking Description
participants and outcome assessors are blinded to which group participants are allocated.
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group Control
Arm Type
Placebo Comparator
Arm Description
participants are administered 2mL of 0.9% placebo at the end of procedure.
Arm Title
group Flumazenil
Arm Type
Active Comparator
Arm Description
participants are administered 0.2mg (2mL) of flumazenil at the end of procedure.
Intervention Type
Drug
Intervention Name(s)
Flumazenil
Other Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of postoperative nausea and vomiting (PONV)
Description
assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting
Time Frame
up to 24 hours after participants discharge from day surgery center.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong-Hyop Kim, M.D. Ph.D
Organizational Affiliation
Konkuk University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
State/Province
Seoul-T'ǔkpyǒlshi
ZIP/Postal Code
05030
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reversal of Remimazolam by a Single Dose of Flumazenil
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