Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Postoperative delirium
研究概览
简要总结
Delirium is defined as an acute onset and fluctuating course of mental status change with inattention and an altered level of consciousness. Delirium in the postoperative period can be divided into emergence delirium and postoperative delirium, based on the time of onset (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious problem affecting the safety of patients and medical personnel. Clinical studies demonstrated that postoperative delirium is associated with worse outcomes such as prolonged hospital stay, postdischarge institutionalization, and increased mortality (Ely et al., 2004a; Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the development of postoperative delirium, including patient's medical condition, administration of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005; Robinson & Eiseman, 2008; Deiner & Silverstein, 2009). Sevoflurane anesthesia have been reported to be associated with more emergence delirium in pediatric patients, when compared with propofol anesthesia. It is not clear if propofol anesthesia will benefit the geriatric patients on postoperative delirium, when compared with sevoflurane anesthesia. We hypothesize that propofol anesthesia will reduce the rate of postoperative delirium by 50% when compared with sevoflurane anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Physical Status classification (ASA_PS) class I-III
- •Aged 60 years or above
- •Elective major surgery under general anesthesia
排除标准
- •ASA_PS>=IV
- •Aged under 60 yr old
- •Body mass index (BMI) >30
- •Neurologic disease
- •Cardiac surgery and neurologic surgery
- •Anticonvulsant drugs
- •Chronic analgesics intake
- •Participating in the investigation of another study
研究组 & 干预措施
P
Anesthesia maintenance with propofol+remifentanil
干预措施: Propofol (Drug)
S
Anesthesia maintenance with sevoflurane+remifentanil
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Postoperative delirium
时间窗: at 24 postoperative hours
Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours
次要结局
- Length of postanesthesia care unit (PACU) stay(up to 2 hours after PACU admitting)
- Hemodynamic parameters(5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure)
- Incidence of postoperative nausea and vomiting(24 postoperative hours)
- Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score(1,2,3,7 postoperative days)
- Postoperative delirium(2st, 3st, 7st postoperative days)
- Postoperative Stroke(1st, 2st, 3st, 7st postoperative days)
研究者
Wei Mei
Associate Professor
Huazhong University of Science and Technology
