Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 主要终点
- Central venous pressure
研究概览
简要总结
To explore the effect of induction and maintenance of anesthesia with etomidate on hemodynamics and oxidative stress in diabetic 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years;
- •Diabetic patients preparing for elective surgery;
- •Body mass index is between 16 and 30 kg/m2;
- •Blood glucose is under 8.3 mmol/kg by oral antidiabetic agents or diet control;
- •American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ;
- •Expected operation duration is between 2 and 8 h;
- •Signed informed consent form.
排除标准
- •Severe cardiac, cerebral, liver, kidney, lung, endocrine disease or infectious disease;
- •Chemotherapy or immunotherapy before the surgery;
- •Allergy to trial drug or other contraindication;
- •Expected or history of difficult airway;
- •Suspected abuse of narcotic analgesia;
- •Diseases of neuromuscular system;
- •Mentally unstable or has a mental illness;
- •Trend of malignant hyperthermia;
- •Pregnant or breast-feeding women;
- •Attendance of other trial past 30 days.
研究组 & 干预措施
Group E
Etomidate was used in both induction and maintenance of anesthesia.
干预措施: Remifentanil (Drug)
Group E
Etomidate was used in both induction and maintenance of anesthesia.
干预措施: midazolam (Drug)
Group E
Etomidate was used in both induction and maintenance of anesthesia.
干预措施: Penehyclidine Hydrochloride Injection (Drug)
Group E
Etomidate was used in both induction and maintenance of anesthesia.
干预措施: Etomidate (Drug)
Group E
Etomidate was used in both induction and maintenance of anesthesia.
干预措施: Fentanyl (Drug)
Group E
Etomidate was used in both induction and maintenance of anesthesia.
干预措施: Cisatracurium Besilate (Drug)
Group E
Etomidate was used in both induction and maintenance of anesthesia.
干预措施: Sevoflurane (Drug)
Group P
Propofol was used in both induction and maintenance of anesthesia.
干预措施: midazolam (Drug)
Group P
Propofol was used in both induction and maintenance of anesthesia.
干预措施: Propofol (Drug)
Group P
Propofol was used in both induction and maintenance of anesthesia.
干预措施: Fentanyl (Drug)
Group P
Propofol was used in both induction and maintenance of anesthesia.
干预措施: Cisatracurium Besilate (Drug)
Group P
Propofol was used in both induction and maintenance of anesthesia.
干预措施: Remifentanil (Drug)
Group P
Propofol was used in both induction and maintenance of anesthesia.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Central venous pressure
时间窗: from 10 minutes before induction to 1 h after the surgery
Central venous pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
Heart rate
时间窗: from 10 minutes before induction to 1 h after the surgery
Heart rate will be recorded 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
Respiratory rate
时间窗: from 10 minutes before induction to 1 h after the surgery
Respiratory rate will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
Oxygen saturation
时间窗: from 10 minutes before induction to 1 h after the surgery
Oxygen saturation will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
Mean arterial pressure
时间窗: from 10 minutes before induction to 1 h after the surgery
Mean arterial pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
Blood glucose
时间窗: from 10 minutes before induction to 1 h after the surgery
Blood glucose will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5). Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
Insulin
时间窗: from 10 minutes before induction to 1 h after the surgery
Insulin will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5). Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.
次要结局
- Super oxide dismutase(from 10 minutes before induction to 1 h after the surgery)
- Glutathione(from 10 minutes before induction to 1 h after the surgery)
- Xanthine oxidase(from 10 minutes before induction to 1 h after the surgery)