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NCT05382806 Clinical Trial

Reversal of Remimazolam by a Single Dose of Flumazenil

Postoperative Nausea Clinical Trial

Official title:
Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05382806
Other study ID # KUMC2021-11-058
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2, 2022
Est. completion date May 13, 2023

Study information
Verified date May 2023
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 224
Est. completion date May 13, 2023
Est. primary completion date May 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of Konkuk University Medical Center Seoul Seoul-T'ukpyolshi

Sponsors (1)
Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of postoperative nausea and vomiting (PONV) assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting up to 24 hours after participants discharge from day surgery center.
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