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Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

Information source: Tang-Du Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myoclonus

Intervention: Low-dose Dexmedetomidine (Drug); High-dose dexmedetomidine (Drug); normal saline (Drug); Etomidate (Drug); midazolam,fentanyl,rocuronium (Drug); propofol,remifentanil,cis atracurium (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Tang-Du Hospital

Official(s) and/or principal investigator(s):
LI yumin, PHD, Principal Investigator, Affiliation: The Fourth Military Medical University

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.

Clinical Details

Official title: Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus During General Anesthesia Induction Period

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

myoclonus level

Plasma homovanillic acid concentration(PHVA)

Secondary outcome:

Ramsay sedation score

Narcotrend index

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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%

Locations and Contacts

Additional Information

Related publications:

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.

Doenicke AW, Roizen MF, Kugler J, Kroll H, Foss J, Ostwald P. Reducing myoclonus after etomidate. Anesthesiology. 1999 Jan;90(1):113-9.

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.

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.

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.

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.

Starting date: September 2015
Last updated: August 7, 2015

Page last updated: August 23, 2015

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