The Comparison of Efficacy and Safety of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients --A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 主要终点
- Effect Compartment Concentration
研究概览
简要总结
Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Scheduled for Endotracheal intubated and general anesthesia for general surgery patients.
- •Age 60-75 yrs.
- •American Society of Anesthesia (ASA) classification I-II.
- •Expected time of surgery is less than 3 hours. -
排除标准
- •Body mass index is more than 36kg/m
- •Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg.
- •Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis.
- •Long term used hormone or adrenal suppression.
- •Allergy to trial drug or other contraindication.
- •Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation.
- •Abuse of narcotic analgesia or suspected.
- •Neuromuscular diseases.
- •Mentally unstable or has a mental illness.
- •Malignant Hyperthermia.
- •Pregnant or breast-feeding women.
- •Attended other trial past 30 days. -
研究组 & 干预措施
Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
干预措施: Bispectral index(BIS) monitor (Device)
Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
干预措施: Remifentanil (Drug)
Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
干预措施: Cisatracurium (Drug)
Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
干预措施: Sufentanil (Drug)
Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
干预措施: Remifentanil (Drug)
Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
干预措施: Cisatracurium (Drug)
Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
干预措施: Sufentanil (Drug)
Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
干预措施: Bispectral index(BIS) monitor (Device)
结局指标
主要结局
Effect Compartment Concentration
时间窗: From the beginning of induction to paitens'left of PACU, up to 4 hours
The effect compartment concentration of etomidate or propofol are recorded at three time points,including time that patient's loss of eyelash reflex,after 30 minutes of loss of eyelash reflex and when the patient is awake （call then open their eyes).
次要结局
- vital signs(From the beginning of induction to skin closure, up to 3 hours)
- The amount of drugs(From the beginning of induction to skin closure, up to 3 hours)
- Adrenal function(From entering the operating room to 48 h after induction of anesthesia.)