Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus During General Anesthesia Induction Period
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 132
- 主要终点
- myoclonus level
研究概览
简要总结
By observing the difference of plasma homovanillic acid concentrations and brain electrical consciousness monitoring Narcotrend index, study the possible mechanism of influencing Etomidate induced myoclonus with Dexmedetomidine pretreatment during general anesthesia induction period.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the informed consent
- •American Society of Anesthesiologists (ASA)classification:class I~II;undergoing elective surgery patients
- •Aged between 18 and 55, 49-67 kg weight
- •Body Mass Index（BMI）： 20-30 kg/m2
- •Did not use any analgesic or sedatives drugs within 24 h pre-operation
排除标准
- •Recently patients undergoing sedative drugs and antidepressant treatment
- •Serious vision, hearing impairment or other reasons can not communicate
- •Serious neurological disease, pregnancy, diseases of the cardiovascular system；
- •BMI is Less than the standard 80% or higher than the standard 120%
研究组 & 干预措施
Low-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.
干预措施: Low-dose Dexmedetomidine (Drug)
Low-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.
干预措施: Etomidate (Drug)
Low-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.
干预措施: midazolam，fentanyl，rocuronium (Drug)
Low-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.
干预措施: propofol，remifentanil，cis atracurium (Drug)
High-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.
干预措施: High-dose dexmedetomidine (Drug)
High-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.
干预措施: Etomidate (Drug)
High-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.
干预措施: midazolam，fentanyl，rocuronium (Drug)
High-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.
干预措施: propofol，remifentanil，cis atracurium (Drug)
normal saline Control group
-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
干预措施: normal saline (Drug)
normal saline Control group
-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
干预措施: Etomidate (Drug)
normal saline Control group
-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
干预措施: midazolam，fentanyl，rocuronium (Drug)
normal saline Control group
-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
干预措施: propofol，remifentanil，cis atracurium (Drug)
结局指标
主要结局
myoclonus level
时间窗: when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes
* Level 0 ：no myoclonus happened; * Level 1 ：mild, tiny movement, one part of the body such as a finger or shoulder movement; * Level 2 ：moderate ,2 pieces of different muscle or slight movement of the muscle groups, such as face or legs; * Level 3 ：severely, 2 pieces or more muscle contracture intensity, such as fast outreach of limbs
Plasma homovanillic acid concentration（PHVA）
时间窗: Measured when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes; if myoclonus does not appear,measured at 5 minutes after emulsion injection is completed.
次要结局
- Ramsay sedation score(1 min after entering the operating room; 1 min after dexmedetomidine injection is completed; 1 min after emulsion injection is completed;5 minutes after emulsion injection is completed；)
- Narcotrend index(1 min after entering the operating room; 1 min after dexmedetomidine injection is completed; 1 min after emulsion injection is completed;5 minutes after emulsion injection is completed；)