Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Time to follow verbal command
研究概览
简要总结
The goal of this prospective, randomized study is to compare recovery characteristics between remimazolam anesthesia with flumazenil and desflurane anesthesia in patients undergoing closed reduction of nasal bone fracture. The main question this study aims to answer is:
- Is there statistically significant difference in time from discontinuation of the anesthetic agent up to patient's response to verbal command between these two groups?
Participants will receive either remimazolam or desflurane for the maintenance of general anesthesia. When the surgery ends, the anesthetic agent will be stopped. For Remimazolam group, flumazenil will be administered as an antagonist of remimazolam.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 19 and 75 years
- •American Society of Anesthesiologists physical status (ASA PS) of I-II
- •Patients undergoing elective closed reduction of nasal bone fracture
排除标准
- •Patient who cannot understand the process of this study
- •Cognitive, visual or hearing impairment
- •Chronic use of antipsychotic medications or medications for sleeping problem
- •Use of benzodiazepine
- •Patient with kidney or liver disease
- •Body mass index (BMI) >30 kg/m^2
研究组 & 干预措施
Remimazolam group
receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam.
干预措施: Remimazolam (Drug)
Desflurane group
receives desflurane for the maintenance of general anesthesia.
干预措施: Desflurane (Drug)
结局指标
主要结局
Time to follow verbal command
时间窗: from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes
Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot
次要结局
- time to eye opening(from discontinuation of anesthetic agent to eye opening, up to 30 minutes)
- Incidence of agitation during emergence period(from discontinuation of anesthetic agent to 2 minutes after extubation)
- Mean arterial blood pressure(from 5 minutes before anesthesia induction to end of anesthesia)
- time to extubation(form discontinuation of anesthetic agent to extubation, up to 30 minutes)
研究者
SO YOUNG LEE
Assistant professor
Daegu Catholic University Medical Center