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Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02518789
Recruitment Status : Unknown
Verified August 2015 by Tang-Du Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

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.

Condition or disease Intervention/treatment Phase
Myoclonus Drug: Low-dose Dexmedetomidine Drug: High-dose dexmedetomidine Drug: normal saline Drug: Etomidate Drug: midazolam,fentanyl,rocuronium Drug: propofol,remifentanil,cis atracurium Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects and Mechanism of Pretreatment With Dexmedetomidine to Etomidate Induce Myoclonus During General Anesthesia Induction Period
Study Start Date : September 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-dose Dexmedetomidine
-Pretreatment before anesthesia induction:Intravenous injection dexmedetomidine 0.5 µg/kg,completed within 15 minutes.
Drug: Low-dose Dexmedetomidine
Pretreatment:Intravenous injection dexmedetomidine 0.5 µg/kg ,completed within 15 minutes.
Other Name: Yisi

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.

Other Name: Fuerli

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
Other Name: Liyuexi,Fentanyl Citrate Injection,Aikesong

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
Other Name: Propofol Injection,Ruifen,Cisatracurium Besylate Injection

Experimental: High-dose Dexmedetomidine
-Pretreatment before anesthesia induction:Intravenous injection dexmedetomidine 1 µg/kg,completed within 15 minutes.
Drug: High-dose dexmedetomidine
Pretreatment:Intravenous injection dexmedetomidine 1 µg/kg ,completed within 15 minutes.
Other Name: Yisi

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.

Other Name: Fuerli

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
Other Name: Liyuexi,Fentanyl Citrate Injection,Aikesong

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
Other Name: Propofol Injection,Ruifen,Cisatracurium Besylate Injection

Placebo Comparator: normal saline Control group
-Pretreatment before anesthesia induction:Intravenous injection normal saline equal quantity,completed within 15 minutes.
Drug: normal saline
Pretreatment:Intravenous injection normal saline equal quantity,completed within 15 minutes.
Other Name: Sodium Chloride Physiological Solution

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.

Other Name: Fuerli

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
Other Name: Liyuexi,Fentanyl Citrate Injection,Aikesong

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
Other Name: Propofol Injection,Ruifen,Cisatracurium Besylate Injection




Primary Outcome Measures :
  1. 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

  2. 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 Measures :
  1. 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; ]
  2. 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; ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518789


Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Principal Investigator: LI yumin, PHD Fourth Military Medical University
Publications:
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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT02518789    
Other Study ID Numbers: Tangdu-Eto-myo
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015
Keywords provided by Tang-Du Hospital:
myoclonus
Etomidate
Dexmedetomidine
Additional relevant MeSH terms:
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Myoclonus
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Fentanyl
Midazolam
Dexmedetomidine
Remifentanil
Propofol
Etomidate
Atracurium
Rocuronium
Cisatracurium
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid