Clinical trial NCT02518789: Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus
Official title: Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus During General Anesthesia Induction Period
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myoclonus
Keywords: myoclonus
Etomidate
Dexmedetomidine
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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%

Primary outcomes:
measure: myoclonus level
timeFrame: when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes
measure: Plasma homovanillic acid concentration（PHVA）
timeFrame: 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 outcomes:
measure: Ramsay sedation score
timeFrame: 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；
measure: Narcotrend index
timeFrame: 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；
Other outcomes:
Locations:
Study officials:
affiliation: Air Force Military Medical University, China
name: LI yumin, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwarzkopf KR, Hueter L, Simon M, Fritz HG. Midazolam pretreatment reduces etomidate-induced myoclonic movements. Anaesth Intensive Care. 2003 Feb;31(1):18-20. doi: 10.1177/0310057X0303100103.
citation: 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. doi: 10.1177/0310057X8801600207.
citation: Doenicke AW, Roizen MF, Kugler J, Kroll H, Foss J, Ostwald P. Reducing myoclonus after etomidate. Anesthesiology. 1999 Jan;90(1):113-9. doi: 10.1097/00000542-199901000-00017.
citation: 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. doi: 10.1097/00000542-200310000-00022.
citation: 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. doi: 10.1213/00000539-199108000-00015.
citation: 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. doi: 10.1093/bja/86.5.650.
citation: 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.