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

Primary Purpose

Delirium, Hemodynamic Instability

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Propofol
Etomidate
Bispectral Index Monitor
Induction of anesthesia
Maintenance of anesthesia
Tracheal Intubation
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Target Controlled Infusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Etomidate

    Propofol

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Blood pressure
    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

    Heart rate
    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.
    Delirium
    Using Confusion Assessment Method for the Intensive Care Unit(CAM-ICU) to screening of delirium.
    Life quality
    using the Activities of Daily Living (ADL) to assess the life quality one month after the surgery.
    Number of Participants with Serious and Non-Serious Adverse Events
    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
    Time of recovery from anesthesia
    Bispectral index (BIS) value
    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.
    onset time
    The time period from TCI etomidate or propofol to the disappearance of eyelash reflex.

    Full Information

    First Posted
    August 18, 2014
    Last Updated
    December 31, 2015
    Sponsor
    Xijing Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02644980
    Brief Title
    Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery
    Official Title
    Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery,A Randomized Controlled Double-Blinded Study
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Xijing Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium, Hemodynamic Instability
    Keywords
    Target Controlled Infusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Etomidate
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Propofol
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Etomidate
    Other Intervention Name(s)
    Fuerli
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Bispectral Index Monitor
    Other Intervention Name(s)
    BIS
    Intervention Description
    BIS monitored from beginning of anesthesia induction to the end of the surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Induction of anesthesia
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Maintenance of anesthesia
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Tracheal Intubation
    Intervention Description
    After the induction of anesthesia, Tracheal intubation is performed.
    Primary Outcome Measure Information:
    Title
    Blood pressure
    Description
    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.
    Time Frame
    from the beginning of induction to the surgery over, up to 6 hrs.
    Secondary Outcome Measure Information:
    Title
    Heart rate
    Description
    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.
    Time Frame
    from the beginning of induction to the surgery over, up to 6 hrs.
    Title
    Delirium
    Description
    Using Confusion Assessment Method for the Intensive Care Unit(CAM-ICU) to screening of delirium.
    Time Frame
    The right moment of patients'leaving off PACU, expected to be 2 h from the end the of operation
    Title
    Life quality
    Description
    using the Activities of Daily Living (ADL) to assess the life quality one month after the surgery.
    Time Frame
    at the time of one month right after the surgery
    Title
    Number of Participants with Serious and Non-Serious Adverse Events
    Description
    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
    Time Frame
    Up to 1 month
    Title
    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.
    Title
    Bispectral index (BIS) value
    Description
    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.
    Time Frame
    from the beginning of induction to the surgery over, up to 6 hrs.
    Title
    onset time
    Description
    The time period from TCI etomidate or propofol to the disappearance of eyelash reflex.
    Time Frame
    The time from TCI etomidate or propofol to the disappearance of eyelash reflex,up to 10 minutes.
    Other Pre-specified Outcome Measures:
    Title
    Respiratory rates(HR)
    Description
    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.
    Time Frame
    from the beginning of induction to the surgery over, up to 6 hrs.
    Title
    pulse blood oxygen saturation (SPO2)
    Description
    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.
    Time Frame
    from the beginning of induction to the surgery over, up to 6 hrs.
    Title
    Dosage of anesthesia drug
    Description
    record the dosage of the anesthesia drug including propofol and etomidate, sufentanyl and rocuronium used during the period of maintenance of anesthesia.
    Time Frame
    from the beginning of induction of anesthesia to the surgery over, up to 6 hrs.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18~75 years old Selective cardiopulmonary bypass thoracoscopic mitral vales replacement surgery Received heart surgery for the first time New York Heart Association(NYHA) II~III Written informed consent - Exclusion Criteria: Emergency surgery Anticipated survival time <1 yrs Serious heart, brain, liver,kidney,lung,endocrine diseases or serious infection Prolonged use of hormone or history of adrenal suppression disease Severe mediastinal fiber thickening or fibrous adhesions Allergy to experimental drug or other contraindications Occurred or expected occurring of difficulty airway Sure or suspected narcotic analgesics abuse History of neuro-muscular disease Mental instability or metal disease Pregnancy or brest-feeding Participated other clinical trial past 30 days Malignant hyperthermia

    12. IPD Sharing Statement

    Learn more about this trial

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

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