Intraoperative Application of Dexmedetomidine on the Incidence of Postoperative Delirium and Quality of Recovery in Geriatric Patients Undergoing Major Surgery
试验速览
- 阶段
- 3 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
Postoperative agitation (hyperactive delirium) is common following major surgery(incidence was about 20% in our pilot study). Dexmedetomidine was related to a reduced delirium rate when comparing with midazolam in many clinical settings. It is not clear if dexmedetomidine is useful on reducing postoperative delirium. The hypothesis of present study: intraoperative application of dexmedetomidine (0.2ug/kg/h) is is effective (50% reduce) than placebo for reducing of early postoperative delirium and increase postoperative quality of recovery within 24 postoperative hours.
详细描述
After approval from the Institute's Ethics Committee, this study was conducted at Tongji Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study consisted of adult patients, American Society of Anaesthesiologists Physical Status (ASA-PS) I-III, undergoing selective major surgery under general anesthesia. All the patients were randomly assigned to receive dexmedetomidine or placebo during the operation. The primary outcome measure was postoperative delirium assessed by Nursing Delirium Screening Scale (Nu-DESC) every 8 hours within 24 postoperative hours. The secondary outcome was length of postanesthesia care unit (PACU) stay,postoperative hospital length of stay, hemodynamic parameters, the incidence of postoperative nausea and vomiting, and quality of recovery determined by quality of recovery (QOR40; maximum score 200)and Post-operative Quality Recovery Scale (PQRS) in the first 24 h after surgery.
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
- Quadruple (Participant, Care Provider, 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
- •ASA physical status 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
Arm P
Placebo infusion
干预措施: Placebo (Drug)
Arm D
Dexmedetomidine infusion
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative delirium
时间窗: every 8 hours within 24 postoperative hours
Postoperative delirium was determined by Nu-DESC every 8 hours within 24 postoperative hours
次要结局
- quality of recovery determined by QOR40 and Postoperative Quality Recovery Scale (PQRS)(24 postoperative hours)
- Postoperative Stroke(1st, 2nd, 3rd, 7th postoperative days)
- Length of PACU stay(during PACU stay)
- hemodynamic parameters(every 5min during operation and every 15min during PACU stay)
- Postoperative delirium(1st, 2nd, 3rd postoperative days)
- incidence of postoperative nausea and vomiting(24 postoperative hours)
研究者
Wei Mei
Associate Professor
Huazhong University of Science and Technology