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临床试验/NCT01995214
NCT01995214Unknown4 期

Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Anesthesia maintenance with propofol+remifentanil

干预措施: Propofol (Drug)

S

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Mei

Associate Professor

Huazhong University of Science and Technology

研究点 (1)

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