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The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries

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ClinicalTrials.gov Identifier: NCT02174120
Recruitment Status : Unknown
Verified June 2014 by Liu He, Henan Provincial People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Liu He, Henan Provincial People's Hospital

Brief Summary:
To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.

Condition or disease Intervention/treatment Phase
Target Controlled Infusion General Anesthesia Drug: propofol Drug: etomidate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
During maintenance of anesthesia, etomidate was give by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml to keep bispectral index between 40 to 60.
Drug: etomidate
Other Name: Fu Er Li

Experimental: Group B
During maintenance of anesthesia, Propofol was give by target controlled infusion, the effect-site concentration is 2 to 4 micrograms/ml to keep bispectral index between 40 to 60.
Drug: propofol
Experimental: Group C
During maintenance of anesthesia, etomidate will be given by target controlled infusion for 2 h first, and then propofol will be given by target controlled infusion, the effect-site concentration is 0.3 to 0.6 micrograms/ml and 2 to 4 micrograms/ml, respectively. Bispectral index should be kept between 40 to 60.
Drug: propofol
Drug: etomidate
Other Name: Fu Er Li




Primary Outcome Measures :
  1. Heart rate [ Time Frame: Baseline to the end of the operation, expected to be about 6 h ]
    Heart rate should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.

  2. Blood pressure [ Time Frame: Baseline to the end of the operation, expected to be about 6 h ]
    Blood pressure should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin.

  3. Concentration of cortisol [ Time Frame: from baseline to the end of the operation, expected to be about 6 h ]
    Concentration of cortisol should be recorded before induction, 30 min, 1 h, 2 h after intubation, and immediately when the operation is over.


Secondary Outcome Measures :
  1. Use of vasoactive agent [ Time Frame: from the beginning of induction to the end of the operation, expected to be about 6 h ]
    The name and dose of the vasoactive agents used from the beginning of induction to the end of operation.

  2. The time from stop of remifentanil to awake [ Time Frame: The time from stop of remifentanil to awake, expected to no more than 15 min ]
  3. Severity of agitation [ Time Frame: Within 24 h after the operation ]
  4. Postoperative nausea and vomiting [ Time Frame: Within 24 h after the operation ]
  5. Dose of etomidate and propofol [ Time Frame: From the beginning of induction to the end of the operation, expected to be about 6 h ]
  6. Intraoperative awareness [ Time Frame: From the beginning of induction to the end of the operation, expected to be about 6 h ]
  7. Expense of anesthetics [ Time Frame: From the beginning of induction to the end of the operation, expected to be about 6 h ]
  8. Allergic reaction [ Time Frame: From beginning of induction to 24 h after the operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form

Exclusion Criteria:

  • Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days
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Responsible Party: Liu He, Physician, Henan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02174120    
Other Study ID Numbers: 20140623
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Propofol
Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics