Ambulatory Surgery, Flumazenil Adverse Reaction, Postoperative Nausea, Remimazolam
Conditions
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.
Interventions
DRUGFlumazenil
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.
Sponsors
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
participants and outcome assessors are blinded to which group participants are allocated.
Intervention model description
Participants are administered either flumazenil (group flumazenil) or 0.9% normal saline (group control).
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed