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Clinical trial

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

ID
Name
KUMC2021-11-058
Description
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.
Trial arms
Trial start
2022-08-02
Estimated PCD
2023-05-10
Trial end
2023-05-13
Status
Completed
Treatment
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.
Arms:
group Control, group Flumazenil
Other names:
placebo
Size
224
Primary endpoint
the incidence of postoperative nausea and vomiting (PONV)
up to 24 hours after participants discharge from day surgery center.
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'participants and outcome assessors are blinded to which group participants are allocated.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 224, 'type': 'ACTUAL'}}
Updated at
2023-05-19

1 organization

1 product

4 indications

Organization
Konkuk University Medical Center
Product
Flumazenil
Indication
Flumazenil Adverse Reaction
Indication
Ambulatory Surgery
Indication
postoperative nausea
Indication
Remimazolam