Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus
NCT ID: NCT02518789
Last Updated: 2015-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
132 participants
INTERVENTIONAL
2015-09-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.
Low-dose Dexmedetomidine
Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.
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.
midazolam，fentanyl，rocuronium
Anesthesia induction：Intravenous injection midazolam 0.03 \~ 0.05 mg/kg, fentanyl 5 \~ 8 g/kg, rocuronium 0.6 mg/kg
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
High-dose Dexmedetomidine
-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.
High-dose dexmedetomidine
Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.
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.
midazolam，fentanyl，rocuronium
Anesthesia induction：Intravenous injection midazolam 0.03 \~ 0.05 mg/kg, fentanyl 5 \~ 8 g/kg, rocuronium 0.6 mg/kg
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
normal saline Control group
-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
normal saline
Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.
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.
midazolam，fentanyl，rocuronium
Anesthesia induction：Intravenous injection midazolam 0.03 \~ 0.05 mg/kg, fentanyl 5 \~ 8 g/kg, rocuronium 0.6 mg/kg
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
Interventions
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Low-dose Dexmedetomidine
Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.
High-dose dexmedetomidine
Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.
normal saline
Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.
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.
midazolam，fentanyl，rocuronium
Anesthesia induction：Intravenous injection midazolam 0.03 \~ 0.05 mg/kg, fentanyl 5 \~ 8 g/kg, rocuronium 0.6 mg/kg
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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%
18 Years
55 Years
ALL
No
Sponsors
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Tang-Du Hospital
OTHER
Responsible Party
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Principal Investigators
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LI yumin, PHD
Role: PRINCIPAL_INVESTIGATOR
Air Force Military Medical University, China
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Tangdu-Eto-myo
Identifier Type: -
Identifier Source: org_study_id
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