A Comparison Between Propofol and Etomidate in Hysteroscopy on Effect of Postoperative Sedation and Cognitive Function in Elderly Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 主要终点
- Mean arterial pressure
研究概览
简要总结
To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 60 and 80 years
- •Selective hysteroscopic operation
- •American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
- •Signed informed consent form
- •Expected operation duration is within 60 minutes
排除标准
- •Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis
- •Long use of hormone or history of adrenal suppression
- •Allergy to trial drug or other contraindication
- •History or expected difficult airway
- •Identified, suspected abuse or long use of narcotic analgesia
- •Neuromuscular diseases
- •Mentally unstable or has a mental illness
- •Dysfunction of communication
- •Trend of malignant hyperthermia
- •Pregnant or breast-feeding women
- •Attended other trial past 30 days;
研究组 & 干预措施
Group E
Etomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10~15 μg/kg/min and 0.2~0.4 μg/kg/min, respectively.
干预措施: Etomidate (Drug)
Group E
Etomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10~15 μg/kg/min and 0.2~0.4 μg/kg/min, respectively.
干预措施: Remifentanil (Drug)
Group E
Etomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10~15 μg/kg/min and 0.2~0.4 μg/kg/min, respectively.
干预措施: Anesthesia induction (Drug)
Group P
Propofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50~75 μg/kg/min and 0.2~0.4 μg/kg/min, respectively.
干预措施: Propofol (Drug)
Group P
Propofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50~75 μg/kg/min and 0.2~0.4 μg/kg/min, respectively.
干预措施: Remifentanil (Drug)
Group P
Propofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50~75 μg/kg/min and 0.2~0.4 μg/kg/min, respectively.
干预措施: Anesthesia induction (Drug)
结局指标
主要结局
Mean arterial pressure
时间窗: Immediately after the entrance to the operating room until until 60 minutes after the operation
Mean arterial pressure will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Pulse oxygen saturation
时间窗: Immediately after the entrance to the operating room until until 60 minutes after the operation
Pulse oxygen saturation will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Heart rate
时间窗: Immediately after the entrance to the operating room until until 60 minutes after the operation
heart rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Respiratory rate
时间窗: Immediately after the entrance to the operating room until until 60 minutes after the operation
Respiratory rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
Narcotrend index
时间窗: Immediately after the entrance to the operating room until until 60 minutes after the operation
Narcotrend index will be recorded immediately after the entance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.
次要结局
- Score of Minimum Mental State Examination(1 day before the operation to 45 minutes after the operation)
- Verbal Fluency test(1 day before the operation to 60 minutes after the operation)
- Cerebral injury parameters(Immediately after the entrance to the operating room until until 60 minutes after the operation)
- Length of stay(from the date of admission to the day of discharge, expected to 3 days)
研究者
Wenying Song
Anesthesiologist
Shaanxi Provincial People's Hospital