Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

NCT02518789 | Unknown Phase 4

• 1 other identifier: Tangdu-Eto-myo
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myoclonus

Keywords

myoclonus; Etomidate; Dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

Secondary Outcomes (2)

• 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；

• 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；

Study Arms (3)

Low-dose Dexmedetomidine

EXPERIMENTAL

-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.

Drug: Low-dose Dexmedetomidine; Drug: Etomidate; Drug: midazolam，fentanyl，rocuronium; Drug: propofol，remifentanil，cis atracurium

High-dose Dexmedetomidine

EXPERIMENTAL

-Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.

Drug: High-dose dexmedetomidine; Drug: Etomidate; Drug: midazolam，fentanyl，rocuronium; Drug: propofol，remifentanil，cis atracurium

normal saline Control group

PLACEBO COMPARATOR

-Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.

Drug: normal saline; Drug: Etomidate; Drug: midazolam，fentanyl，rocuronium; Drug: propofol，remifentanil，cis atracurium

Interventions

Low-dose Dexmedetomidine DRUG

Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.

Also known as: Yisi

Low-dose Dexmedetomidine

High-dose dexmedetomidine DRUG

Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.

Also known as: Yisi

High-dose Dexmedetomidine

normal saline DRUG

Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.

Also known as: Sodium Chloride Physiological Solution

normal saline Control group

Etomidate DRUG

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.

Also known as: Fuerli

High-dose Dexmedetomidine; Low-dose Dexmedetomidine; normal saline Control group

midazolam，fentanyl，rocuronium DRUG

Anesthesia induction：Intravenous injection midazolam 0.03 \~ 0.05 mg/kg, fentanyl 5 \~ 8 g/kg, rocuronium 0.6 mg/kg

Also known as: Liyuexi，Fentanyl Citrate Injection，Aikesong

High-dose Dexmedetomidine; Low-dose Dexmedetomidine; normal saline Control group

propofol，remifentanil，cis atracurium DRUG

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

Also known as: Propofol Injection，Ruifen，Cisatracurium Besylate Injection

High-dose Dexmedetomidine; Low-dose Dexmedetomidine; normal saline Control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Tang-Du Hospital: lead

Related Publications (7)

• 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.

  PMID: 12635389 BACKGROUND

• 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.

  PMID: 3394909 BACKGROUND

• 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.

  PMID: 9915320 BACKGROUND

• 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.

  PMID: 14508322 BACKGROUND

• 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.

  PMID: 1649559 BACKGROUND

• 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.

  PMID: 11575340 BACKGROUND

• 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.

  PMID: 20018300 BACKGROUND

MeSH Terms

Conditions

Myoclonus

Interventions

Dexmedetomidine; Saline Solution; Etomidate

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• LI yumin, PHD

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 10, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 10, 2015

Record last verified: 2015-08