Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

Myoclonus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02518789
• Other study ID #: Tangdu-Eto-myo
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 3, 2015
• Last updated: August 7, 2015
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: August 2015
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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%

Study Design

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

Related Conditions & MeSH terms

• Myoclonus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

References & Publications (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myoclonus level	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	when myoclonus occurs after emulsion injection is completed,assessed up to 5 minutes	Yes
Primary	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.	Yes
Secondary	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;	Yes
Secondary	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;	Yes