NCT05382806

Reversal of Remimazolam by a Single Dose of Flumazenil

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Flumazenil Adverse Reaction
• Ambulatory Surgery
• Postoperative Nausea
• Remimazolam

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-05-10
• Completion: 2023-05-13
• First posted: 2022-05-19
• Last updated: 2023-05-19

Locations

1 site across 1 country: South Korea