Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam During Non-cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11,927
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
This research project is an observational cohort study by prospective chart review of patients that underwent surgery in multi-centers, China, in the years 2020-2022. The purpose of this study is to compare the occurrence of postoperative delirium With Midazolam and Without Midazolam During Non-cardiac Surgery in Elders.
详细描述
Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present.
The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted.
The postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted.
Preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten.
The association of various preoperative,intraoperative and postoperative factors with POD will be determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Geriatric surgical patients ≥65 years old Underwent elective non-cardiac surgery
排除标准
- •History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.; The operation was cancelled due to various reasons after the patient was enrolled; severe liver disease; severe renal dysfunction defined as either having creatinine clearance < 30 ml/min or being dialysis-dependent; Patients who undergo second operation in a short period; Refused to participate in the study.
研究组 & 干预措施
Midazolam
Midazolam as a premedication was given as the patient is taken to the operating room and typically within 15 minutes of anesthetic induction.
干预措施: Midazolam (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Day 7 postoperatively
Occurrence of delirium on any postoperative day, as assessed using the 3D-CAM or CAM-ICU daily
次要结局
- the incidence of survival rate(1 year)
研究者
Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Chinese PLA General Hospital