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Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery

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: NCT02644980
Recruitment Status : Unknown
Verified December 2015 by Xijing Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Brief Summary:
For patients requiring the heart valve replacement surgery, heart function is injured in different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular system has important clinical meanings. Etomidate has slight effect on the cardiovascular system, often used in the induction of anesthesia, however target controlled infusion etomidate in maintenance of anesthesia is less used. So, the trial is designed to observe the application value of TCI etomidate in thoracoscopic mitral valve replacement surgery.

Condition or disease Intervention/treatment Phase
Delirium Hemodynamic Instability Drug: Propofol Drug: Etomidate Device: Bispectral Index Monitor Drug: Induction of anesthesia Drug: Maintenance of anesthesia Other: Tracheal Intubation Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery,A Randomized Controlled Double-Blinded Study
Study Start Date : December 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Etomidate
The initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60.
Drug: Etomidate
The initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60.
Other Name: Fuerli

Device: Bispectral Index Monitor
BIS monitored from beginning of anesthesia induction to the end of the surgery.
Other Name: BIS

Drug: Induction of anesthesia
Midazolam 0.03 mg/kg injection vein,Sufentanyl 0.5~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium 0.6mg/kg is given.

Drug: Maintenance of anesthesia
After the intubation, target controlled infusion(TCI) of etomidate or propofol is maintained,rocuronium 0.15mg/kg and sufentanil is given when needed. When the operation is over, the TCI is stopped.

Other: Tracheal Intubation
After the induction of anesthesia, Tracheal intubation is performed.

Experimental: Propofol
The initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60.
Drug: Propofol
The initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60.

Device: Bispectral Index Monitor
BIS monitored from beginning of anesthesia induction to the end of the surgery.
Other Name: BIS

Drug: Induction of anesthesia
Midazolam 0.03 mg/kg injection vein,Sufentanyl 0.5~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium 0.6mg/kg is given.

Drug: Maintenance of anesthesia
After the intubation, target controlled infusion(TCI) of etomidate or propofol is maintained,rocuronium 0.15mg/kg and sufentanil is given when needed. When the operation is over, the TCI is stopped.

Other: Tracheal Intubation
After the induction of anesthesia, Tracheal intubation is performed.




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: from the beginning of induction to the surgery over, up to 6 hrs. ]
    blood pressure(systolic blood pressure and diastolic blood pressure) is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: from the beginning of induction to the surgery over, up to 6 hrs. ]
    Heart rate is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.

  2. Delirium [ Time Frame: The right moment of patients'leaving off PACU, expected to be 2 h from the end the of operation ]
    Using Confusion Assessment Method for the Intensive Care Unit(CAM-ICU) to screening of delirium.

  3. Life quality [ Time Frame: at the time of one month right after the surgery ]
    using the Activities of Daily Living (ADL) to assess the life quality one month after the surgery.

  4. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 1 month ]

    Number of Participants with Serious and Non-Serious Adverse Events including major adverse cardiovascular and cerebrovascular event such as cardiac infraction,stroke, acute renal failure, re-surgery,and death.

    Safety Issue?: Yes


  5. Time of recovery from anesthesia [ Time Frame: from the time TCI is stopped to the time patients' eyes open after the surgery, up to 30 minutes. ]
  6. Bispectral index (BIS) value [ Time Frame: from the beginning of induction to the surgery over, up to 6 hrs. ]
    BIS is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.

  7. onset time [ Time Frame: The time from TCI etomidate or propofol to the disappearance of eyelash reflex,up to 10 minutes. ]
    The time period from TCI etomidate or propofol to the disappearance of eyelash reflex.


Other Outcome Measures:
  1. Respiratory rates(HR) [ Time Frame: from the beginning of induction to the surgery over, up to 6 hrs. ]
    Respiratory rate is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.

  2. pulse blood oxygen saturation (SPO2) [ Time Frame: from the beginning of induction to the surgery over, up to 6 hrs. ]
    pulse blood oxygen saturation is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.

  3. Dosage of anesthesia drug [ Time Frame: from the beginning of induction of anesthesia to the surgery over, up to 6 hrs. ]
    record the dosage of the anesthesia drug including propofol and etomidate, sufentanyl and rocuronium used during the period of maintenance of anesthesia.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18~75 years old
  2. Selective cardiopulmonary bypass thoracoscopic mitral vales replacement surgery
  3. Received heart surgery for the first time
  4. New York Heart Association(NYHA) II~III
  5. Written informed consent -

Exclusion Criteria:

  1. Emergency surgery
  2. Anticipated survival time <1 yrs
  3. Serious heart, brain, liver,kidney,lung,endocrine diseases or serious infection
  4. Prolonged use of hormone or history of adrenal suppression disease
  5. Severe mediastinal fiber thickening or fibrous adhesions
  6. Allergy to experimental drug or other contraindications
  7. Occurred or expected occurring of difficulty airway
  8. Sure or suspected narcotic analgesics abuse
  9. History of neuro-muscular disease
  10. Mental instability or metal disease
  11. Pregnancy or brest-feeding
  12. Participated other clinical trial past 30 days
  13. Malignant hyperthermia

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02644980    
Other Study ID Numbers: XJZH20140722
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Keywords provided by Xijing Hospital:
Target Controlled Infusion
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Anesthetics
Propofol
Etomidate
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General