Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery,A Randomized Controlled Double-Blinded Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 主要终点
- Blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Etomidate (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.
干预措施: Bispectral Index Monitor (Device)
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.
干预措施: Induction of anesthesia (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.
干预措施: Maintenance of anesthesia (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.
干预措施: Tracheal Intubation (Other)
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.
干预措施: Propofol (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.
干预措施: Bispectral Index Monitor (Device)
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.
干预措施: Induction of anesthesia (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.
干预措施: Maintenance of anesthesia (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.
干预措施: Tracheal Intubation (Other)
结局指标
主要结局
Blood pressure
时间窗: 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.
次要结局
- Heart rate(from the beginning of induction to the surgery over, up to 6 hrs.)
- Delirium(The right moment of patients'leaving off PACU, expected to be 2 h from the end the of operation)
- Life quality(at the time of one month right after the surgery)
- Number of Participants with Serious and Non-Serious Adverse Events(Up to 1 month)
- Time 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.)
- onset time(The time from TCI etomidate or propofol to the disappearance of eyelash reflex,up to 10 minutes.)