A Strategy to Reduce the Incidence of Post-Operative Delirium in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
研究概览
简要总结
This research is being done to see what effects sedative drugs during surgery have on peoples' thinking processes after they wake up.
详细描述
We give sedative drugs to patients having spinal anesthesia so they are "asleep" (sedated) while we are fixing their broken hips. The spinal anesthesia provides pain relief at the site of surgery, while the sedative drugs keep people "asleep" during the procedure. We want to find out whether the amount of sedation we give might (1) make patients be confused when they wake up or (2) have anything to do with how well patients can do their ordinary daily routines a few months after their surgery.
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, Care Provider, Outcomes Assessor)
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
- •is 65 years of age or older at admission;
- •has surgical treatment of a traumatic hip fracture;
- •has participating surgeon;
- •has Mini-Mental Status Exam score of 15 or higher;
- •able to read/write/speak/hear/understand English;
- •gives informed consent;
- •receives spinal anesthesia
排除标准
- •receives general anesthesia;
- •does not write/write/speak/hear/understand English;
- •has severe chronic obstructive pulmonary disease (COPD);
- •has severe congestive heart failure (CHF);
- •has Mini-Mental Status Exam score less than 15;
- •declines to give informed consent;
- •age less than 65 years at admission;
- •attending surgeon does not participate in study
研究组 & 干预措施
Deeper sedation
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 0. This is the "deeper sedation" arm.
干预措施: Deeper sedation (Device)
Moderate sedation
Patients randomly assigned to this arm will receive enough sedative drugs to keep their level of awareness during the hip fracture repair, as measured by the use of the Observer's Assessment of Awareness/Sedation Scale (OAA/S), at an OAA/S score of 4-5. This is the "moderate sedation" arm.
干预措施: Moderate sedation (Device)
结局指标
主要结局
Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method
时间窗: Postoperative days up to hospital discharge
The presence of delirium is assessed by the confusion assessment method (CAM), during postoperative Day 1 to Day 5 or up to hospital discharge, whichever occurs first. The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
次要结局
- Mortality(12 months post-operative)
- Change in Functional Status(12 months post-operative)
- Clinical Dementia Rating Sum of Boxes (CDR-SOB) Score(12 months post-operative)
- Number of Participants With the Presence of Delirium at 1 Month as Assessed by the Confusion Assessment Method(1 month (30 days) post-intervention)