Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

Overview

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.

Full Title of Study: “Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus During General Anesthesia Induction Period”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2016

Interventions

  • Drug: Low-dose Dexmedetomidine
    • Pretreatment:Intravenous injection dexmedetomidine 0.5 µg/kg ,completed within 15 minutes.
  • Drug: High-dose dexmedetomidine
    • Pretreatment:Intravenous injection dexmedetomidine 1 µg/kg ,completed within 15 minutes.
  • Drug: normal saline
    • Pretreatment:Intravenous injection normal saline equal quantity,completed within 15 minutes.
  • 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.
  • 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
  • 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

Arms, Groups and Cohorts

  • Experimental: Low-dose Dexmedetomidine
    • -Pretreatment before anesthesia induction:Intravenous injection dexmedetomidine 0.5 µg/kg,completed within 15 minutes.
  • Experimental: High-dose Dexmedetomidine
    • -Pretreatment before anesthesia induction:Intravenous injection dexmedetomidine 1 µg/kg,completed within 15 minutes.
  • Placebo Comparator: normal saline Control group
    • -Pretreatment before anesthesia induction:Intravenous injection normal saline equal quantity,completed within 15 minutes.

Clinical Trial Outcome Measures

Primary Measures

  • myoclonus level
    • Time Frame: 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)
    • Time Frame: 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 Measures

  • Ramsay sedation score
    • Time Frame: 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
    • Time Frame: 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;

Participating in This Clinical Trial

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%

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tang-Du Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • LI yumin, PHD, Principal Investigator, Air Force Military Medical University, China

References

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.

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