Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus
Phase 4
- Conditions
- Myoclonus
- Interventions
- Drug: normal salineDrug: midazolam，fentanyl，rocuronium
- Registration Number
- NCT02518789
- Lead Sponsor
- Tang-Du Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
- 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
Exclusion Criteria
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose Dexmedetomidine Low-dose Dexmedetomidine -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes. Low-dose Dexmedetomidine midazolam，fentanyl，rocuronium -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes. Low-dose Dexmedetomidine propofol，remifentanil，cis atracurium -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes. High-dose Dexmedetomidine midazolam，fentanyl，rocuronium -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes. normal saline Control group midazolam，fentanyl，rocuronium -Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes. normal saline Control group normal saline -Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes. High-dose Dexmedetomidine High-dose dexmedetomidine -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes. High-dose Dexmedetomidine propofol，remifentanil，cis atracurium -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes. normal saline Control group propofol，remifentanil，cis atracurium -Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes. Low-dose Dexmedetomidine Etomidate -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes. High-dose Dexmedetomidine Etomidate -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes. normal saline Control group Etomidate -Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
- Primary Outcome Measures
Name Time Method myoclonus level 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 limbsPlasma homovanillic acid concentration（PHVA） 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.
- Secondary Outcome Measures
Name Time Method 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；