Emergence Times and Airway Reactions in General Laryngeal Mask Airway Anesthesia: a Randomized Multicenter Controlled Trial (ACC Baxter)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 4
- 主要终点
- time of emergence from anesthesia
研究概览
简要总结
The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia.
详细描述
The aim of this study is first to assess if desflurane is superior in order to achieve a faster emergence from anesthesia (stating the date of birth) and second if desflurane is non-inferior in the occurrence of airway complications compared to sevoflurane or total intravenous anesthesia with propofol in the setting of laryngeal mask airway.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned anesthesia with use of LMA (laryngeal mask airway)
- •Planned duration of anesthesia between 0.5 and 2 hours
- •Age between 18-75 years
- •Both gender
- •Body mass index (BMI) <35
- •Written informed consent prior to study participation
排除标准
- •Planned additional regional and local anesthesia
- •Contra-indication for the use of a laryngeal mask airway
- •Known allergy or hypersensitivity to any drugs administered during this study
- •Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
- •Participation in a drug or device trial within the previous 30 days.
- •Patients legally unable to give written informed consent.
- •Patients with severe psychiatric disorders
- •Recent (<6 months) history of alcohol or drug abuse
- •Patients with severe neuropsychiatric disorders
- •Non-fluency in German language
研究组 & 干预措施
desflurane
Suprane® Dose: 0.8 MAC / 4-5 vol. % Mode of administration: inhalation with laryngeal mask One application
干预措施: Desflurane (Drug)
sevoflurane
Sevoflurane:
Dose: 0.8 MAC / 1.2-1.4 vol.% Mode of administration: inhalation with laryngeal mask One application
干预措施: Sevoflurane (Drug)
propofol
Propofol Dose: 5-7 mg kg-1 h-1 to maintain a BIS index value between 40 and 60 Mode of administration: intravenous One application
干预措施: propofol (Drug)
结局指标
主要结局
time of emergence from anesthesia
时间窗: up to 15 minutes
time of emergence from anesthesia defined as time between cessation of anesthesia until patient is able to state his/her date of birth on command
次要结局
- Airway reactions (Incidence of intraoperative coughs, laryngospasm)(up to 2 hours)
- Emergence times(up to 15 minutes)