Reversal of Remimazolam by a Single Dose of Flumazenil After Monitored Anesthesia Care in Gynecological Ambulatory Surgery: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- the incidence of postoperative nausea and vomiting (PONV)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
participants and outcome assessors are blinded to which group participants are allocated.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •participants aged over 20 years scheduled for ambulatory gynecologic surgery.
排除标准
- •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
研究组 & 干预措施
group Control
participants are administered 2mL of 0.9% placebo at the end of procedure.
干预措施: Flumazenil (Drug)
group Flumazenil
participants are administered 0.2mg (2mL) of flumazenil at the end of procedure.
干预措施: Flumazenil (Drug)
结局指标
主要结局
the incidence of postoperative nausea and vomiting (PONV)
时间窗: up to 24 hours after participants discharge from day surgery center.
assess PONV with ordinal scale; 0=none, 1= nausea, 2= retching, 3=vomiting
次要结局
未报告次要终点
研究者
Yea-Ji Lee
Professor
Konkuk University Medical Center