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Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

Primary Purpose

Myoclonus

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Low-dose Dexmedetomidine
High-dose dexmedetomidine
normal saline
Etomidate
midazolam，fentanyl，rocuronium
propofol，remifentanil，cis atracurium
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myoclonus focused on measuring myoclonus, Etomidate, Dexmedetomidine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Low-dose Dexmedetomidine

    High-dose Dexmedetomidine

    normal saline Control group

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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
    Plasma homovanillic acid concentration（PHVA）

    Secondary Outcome Measures

    Ramsay sedation score
    Narcotrend index

    Full Information

    First Posted
    August 3, 2015
    Last Updated
    August 7, 2015
    Sponsor
    Tang-Du Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02518789
    Brief Title
    Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus
    Official Title
    Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus During General Anesthesia Induction Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tang-Du Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myoclonus
    Keywords
    myoclonus, Etomidate, Dexmedetomidine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    132 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-dose Dexmedetomidine
    Arm Type
    Experimental
    Arm Description
    -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 0.5 µg/kg，completed within 15 minutes.
    Arm Title
    High-dose Dexmedetomidine
    Arm Type
    Experimental
    Arm Description
    -Pretreatment before anesthesia induction：Intravenous injection dexmedetomidine 1 µg/kg，completed within 15 minutes.
    Arm Title
    normal saline Control group
    Arm Type
    Placebo Comparator
    Arm Description
    -Pretreatment before anesthesia induction：Intravenous injection normal saline equal quantity，completed within 15 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    Low-dose Dexmedetomidine
    Other Intervention Name(s)
    Yisi
    Intervention Description
    Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    High-dose dexmedetomidine
    Other Intervention Name(s)
    Yisi
    Intervention Description
    Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Other Intervention Name(s)
    Sodium Chloride Physiological Solution
    Intervention Description
    Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    Etomidate
    Other Intervention Name(s)
    Fuerli
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    midazolam，fentanyl，rocuronium
    Other Intervention Name(s)
    Liyuexi，Fentanyl Citrate Injection，Aikesong
    Intervention Description
    Anesthesia induction：Intravenous injection midazolam 0.03 ~ 0.05 mg/kg, fentanyl 5 ~ 8 g/kg, rocuronium 0.6 mg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    propofol，remifentanil，cis atracurium
    Other Intervention Name(s)
    Propofol Injection，Ruifen，Cisatracurium Besylate Injection
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    myoclonus level
    Description
    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
    Time Frame
    when myoclonus occurs after emulsion injection is completed，assessed up to 5 minutes
    Title
    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 Outcome Measure Information:
    Title
    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；
    Title
    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；

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    LI yumin, PHD
    Organizational Affiliation
    Air Force Military Medical University, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12635389
    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. doi: 10.1177/0310057X0303100103.
    Results Reference
    background
    PubMed Identifier
    3394909
    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. doi: 10.1177/0310057X8801600207.
    Results Reference
    background
    PubMed Identifier
    9915320
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    14508322
    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. doi: 10.1097/00000542-200310000-00022.
    Results Reference
    background
    PubMed Identifier
    1649559
    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. doi: 10.1213/00000539-199108000-00015.
    Results Reference
    background
    PubMed Identifier
    11575340
    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. doi: 10.1093/bja/86.5.650.
    Results Reference
    background
    PubMed Identifier
    20018300
    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.
    Results Reference
    background

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    Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

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