Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low-dose Dexmedetomidine -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes. |
Drug: Low-dose Dexmedetomidine
Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.
Other Names:
Drug: Etomidate
After 90 seconds of Pretreatment，intravenous infusion of etomidate fat emulsion 0.3mg/kg.
-Does not offer any other drugs within 5 min after completion of etomidate.
Other Names:
Drug: midazolam，fentanyl，rocuronium
Anesthesia induction：Intravenous injection midazolam 0.03 ~ 0.05 mg/kg, fentanyl 5 ~ 8 g/kg, rocuronium 0.6 mg/kg
Other Names:
Drug: propofol，remifentanil，cis atracurium
Anesthesia maintenance：Intravenous infusion of propofol 4 ~ 6 mg/kg/h, remifentanil 0.1 ~ 0.3 μg/kg/min, intermittent intravenous injection of cis atracurium 0.05 ~ 0.1mg/kg
Other Names:
|
| Experimental: High-dose Dexmedetomidine -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes. |
Drug: High-dose dexmedetomidine
Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.
Other Names:
Drug: Etomidate
After 90 seconds of Pretreatment，intravenous infusion of etomidate fat emulsion 0.3mg/kg.
-Does not offer any other drugs within 5 min after completion of etomidate.
Other Names:
Drug: midazolam，fentanyl，rocuronium
Anesthesia induction：Intravenous injection midazolam 0.03 ~ 0.05 mg/kg, fentanyl 5 ~ 8 g/kg, rocuronium 0.6 mg/kg
Other Names:
Drug: propofol，remifentanil，cis atracurium
Anesthesia maintenance：Intravenous infusion of propofol 4 ~ 6 mg/kg/h, remifentanil 0.1 ~ 0.3 μg/kg/min, intermittent intravenous injection of cis atracurium 0.05 ~ 0.1mg/kg
Other Names:
|
| Placebo Comparator: normal saline Control group -Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes. |
Drug: normal saline
Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.
Other Names:
Drug: Etomidate
After 90 seconds of Pretreatment，intravenous infusion of etomidate fat emulsion 0.3mg/kg.
-Does not offer any other drugs within 5 min after completion of etomidate.
Other Names:
Drug: midazolam，fentanyl，rocuronium
Anesthesia induction：Intravenous injection midazolam 0.03 ~ 0.05 mg/kg, fentanyl 5 ~ 8 g/kg, rocuronium 0.6 mg/kg
Other Names:
Drug: propofol，remifentanil，cis atracurium
Anesthesia maintenance：Intravenous infusion of propofol 4 ~ 6 mg/kg/h, remifentanil 0.1 ~ 0.3 μg/kg/min, intermittent intravenous injection of cis atracurium 0.05 ~ 0.1mg/kg
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 limbs
- Plasma 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
- 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；]
Eligibility Criteria
Criteria
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%
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tang-Du Hospital
Investigators
- Principal Investigator: LI yumin, PHD, Air Force Military Medical University, China
Study Documents (Full-Text)
None provided.More Information
Publications
- Doenicke AW, Roizen MF, Kugler J, Kroll H, Foss J, Ostwald P. Reducing myoclonus after etomidate. Anesthesiology. 1999 Jan;90(1):113-9.
- Maze M, Virtanen R, Daunt D, Banks SJ, Stover EP, Feldman D. Effects of dexmedetomidine, a novel imidazole sedative-anesthetic agent, on adrenal steroidogenesis: in vivo and in vitro studies. Anesth Analg. 1991 Aug;73(2):204-8.
- Mizrak A, Koruk S, Bilgi M, Kocamer B, Erkutlu I, Ganidagli S, Oner U. Pretreatment with dexmedetomidine or thiopental decreases myoclonus after etomidate: a randomized, double-blind controlled trial. J Surg Res. 2010 Mar;159(1):e11-6. doi: 10.1016/j.jss.2009.07.031. Epub 2009 Aug 19.
- Paris A, Philipp M, Tonner PH, Steinfath M, Lohse M, Scholz J, Hein L. Activation of alpha 2B-adrenoceptors mediates the cardiovascular effects of etomidate. Anesthesiology. 2003 Oct;99(4):889-95.
- Schwarzkopf KR, Hueter L, Simon M, Fritz HG. Midazolam pretreatment reduces etomidate-induced myoclonic movements. Anaesth Intensive Care. 2003 Feb;31(1):18-20.
- Stockham RJ, Stanley TH, Pace NL, Gillmor S, Groen F, Hilkens P. Fentanyl pretreatment modifies anaesthetic induction with etomidate. Anaesth Intensive Care. 1988 May;16(2):171-6.
- Venn RM, Bryant A, Hall GM, Grounds RM. Effects of dexmedetomidine on adrenocortical function, and the cardiovascular, endocrine and inflammatory responses in post-operative patients needing sedation in the intensive care unit. Br J Anaesth. 2001 May;86(5):650-6.
- Tangdu-Eto-myo