Comparative Effect of Etomidate and Propofol on Major Complications After Abdominal Surgery in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,917
- 试验地点
- 1
- 主要终点
- Number of participants with complications defined by ICD (International codes of diseases)-9
研究概览
简要总结
Elderly patients have high mortality and postoperative complications rate after surgery, especially postoperative cardiac complications. A meta-analysis revealed haemodynamic intraoperative events significantly increased the risk of postoperative cardiac complications.To limit the risk, optimize the intraoperative management of circulation is essential. Anesthetic drug may effect on the haemodynamic intraoperative, reduction of postoperative complications should aimed at choosing the optimal anesthetic drug with minimal effect on haemodynamic.So this study is to explore the comparative efficacy and safety of anesthetic drug (etomidate or propofol) 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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
participants were anesthetized and were unaware of the grouping. Care providers did not know the grouping. Specific investigators who did the intervention were aware of the grouping. The outcome assessors and the data analyzers did not know the grouping.
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 65 and 80 years old.
- •Patients scheduled for elective gastrointestinal surgery under general anesthesia.
排除标准
- •Expected duration of surgery < 1 or >4 hours
- •American Society of Anesthesiologists status >III
- •Body Mass Index < 18 kg/m2 or> 25 kg/m2
- •Cerebrovascular accident occurred within the previous 3 months,such as stroke or transient ischemic attack
- •Unstable angina and myocardial infarction occurred within the previous 3 months
- •Patients with serious hepatic dysfunction ( the serum level of alanine transaminase, conjugated bilirubin, aspartate transaminase, alkaline phosphatase or total bilirubin is 2 folds more than upper normal limit) or renal dysfunction(creatinine clearance rate less than 30 milliliter per minute).
- •Diabetic patients with complication (diabetic ketoacidosis, hyperosmotic coma,all kinds of infection, macroangiopathy, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot).
- •Preoperative blood pressure more than or equal to 180/110 mmHg
- •Confirmed or suspected of narcotic analgesics abusing or long term using
- •Taking corticosteroids or immunosuppressive agents for more than 10 days with the previous 6 months or had history of adrenal suppression or immune system disease.
- •Patients with thyroid hypofunction.
- •Patients with history of asthma.
- •Patients with history of surgery within previous 3 months.
- •Patients allergic or contraindicated to propofol or etomidate
- •Patients participated in other study within the last 30 days
研究组 & 干预措施
etomidate
etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium
干预措施: Etomidate (Drug)
etomidate
etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium
干预措施: Sufentanil (Drug)
etomidate
etomidate is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium
干预措施: Cisatracurium (Drug)
propofol
propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium
干预措施: propofol (Drug)
propofol
propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium
干预措施: Sufentanil (Drug)
propofol
propofol is given for maintenance of general anesthesia,combined with sufentanil and cisatracurium
干预措施: Cisatracurium (Drug)
结局指标
主要结局
Number of participants with complications defined by ICD (International codes of diseases)-9
时间窗: From the moment of giving sufentanil to the moment of discharge from hospital,up to 7 days
次要结局
- the time to discharge from hospital(From end of surgery to discharge from hospital,on an average of 7 days)
- death by 6 months after surgery(from end of surgery to 6 months after surgery)
- the time to awake from anesthesia(From stopping etomidate or propofol infusion to awake, approximately 30 minutes)
- the time to withdraw tracheal tube from anesthesia(From end of etomidate or propofol infusion to recovery of spontaneous breathing and withdrawal of tracheal tube,approximately 30 minutes)
- the time to discharge from post-anesthesia care unit(From admit into post-anesthesia care unit to discharge from post-anesthesia care unit,on an average of 30 minutes)
- Post Operative Nausea And vomiting score(6 hours, 24 hours, 48 hours and 72 hours after end of surgery，approximately 6 hours, 24 hours, 48 hours and 72 hours respectively)
- pain on visual analogue scale(6 hours after end of surgery，approximately 6 hours)
- satisfaction on visual analogue scale by the patients(24 hours after end of surgery)
- comfort on visual analogue scale by the patients(24 hours after end of surgery)
- incidence of hypotension during anesthesia(from start of surgery to end of surgery, on an average of 2.5 hours)
- incidence of hypertension during anesthesia(from start of surgery to end of surgery, on an average of 2.5 hours)
- percentage of patients needed vasoactive agents during anesthesia(from start of surgery to end of surgery, on an average of 2.5 hours)
- concentration of serum Adrenocorticotropichormone(ACTH) by radioimmunoassay(24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively)
- concentration of serum Cortisol by radioimmunoassay(24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively)
- concentration of serum aldosterone by radioimmunoassay(24hours,48hours and 72hours after extubation，approximately 24 hour, 48 hour and 72 hour respectively)
- death by 12 months after surgery(from end of surgery to 12 months after surgery)
研究者
Zhihong LU
Dr.
Air Force Military Medical University, China