Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery
- Conditions
- Hemodynamic InstabilityDelirium
- Interventions
- Device: Bispectral Index MonitorDrug: Induction of anesthesiaDrug: Maintenance of anesthesiaOther: Tracheal Intubation
- Registration Number
- NCT02644980
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
- 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 -
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol 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. Etomidate Maintenance of anesthesia 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. Etomidate Tracheal Intubation 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. Propofol Induction of anesthesia 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. Etomidate Bispectral Index Monitor 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. Propofol Maintenance of anesthesia 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. Propofol Tracheal Intubation 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. Etomidate Induction of anesthesia 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. Propofol Bispectral Index Monitor 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. Etomidate 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.
- Primary Outcome Measures
Name Time Method Blood pressure 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
Name Time Method Heart rate 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.
Delirium 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.
Life quality 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.
Number of Participants with Serious and Non-Serious Adverse Events 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?: YesTime of recovery from anesthesia from the time TCI is stopped to the time patients' eyes open after the surgery, up to 30 minutes. Bispectral index (BIS) value 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.
onset time 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.