Postoperative Delirium in Patients Undergoing Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Post-operative delirium
研究概览
简要总结
In this study, post-operative delirium will be measured in patients undergoing surgery for bladder resection, and associated microRNA biomarkers will be evaluated in patients considered delirious and non-delirious after surgery.
详细描述
With voluntary participation, this study requires participants to complete a self-administered cognitive evaluation (SAGE) before surgery to assess baseline cognitive impairment and early dementia; vital signs will be documented prior to surgery. During surgery, participants will receive a standardized general anesthesia regimen as described in the protocol. Several parameters will be measured during surgery, including bispectral monitoring to measure processed EEG. After surgery, fitness for cognitive evaluation will be determined by the Richmond Agitation-Sedation Scale (RASS) scale, and then emergence delirium will be assessed using the CAM-ICU scale. Fitness for discharge from PACU will be determined by an Aldrete score of 9 or more. Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS-11). Postoperative nausea and vomiting (PONV) level will also be documented. Postoperative Delirium (POD) assessment will be achieved by administering the memorial delirium assessment scale (MDAS) twice a day starting on day 1 through day 3 postoperatively. Pain NRS-11 score and PONV levels will also be documented at each visit. For microRNA testing, blood probes will be collected in 5mL purple top tube at surgical preadmission and post-surgery days one, two and three. Risks associated with participating in this study include normal risk associated with having surgery and general anesthesia; no greater than minimal risk is associated with blood collection. For the participant, there are no immediate anticipated benefits for participating in this study. The importance of the knowledge that is expected to result includes lower post-operative complications as a result of post-operative delirium, faster recovery, and shorter hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age and older
- •ASA II or III
- •Capable of and willing to consent
- •Participants literate in English language
排除标准
- •ASA IV or V
- •Patients with severe visual or auditory impairment
- •Inability to read and/or write in English
- •Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
- •Dementia of Alzheimer's type
- •Parkinson's disease
- •Multiple Sclerosis (MS)
- •Vascular dementia
结局指标
主要结局
Post-operative delirium
时间窗: up to 3 days post-operatively
Evaluate the incidence of and risk factors for POD in patients undergoing radical cystectomy utilizing the Memorial Delirium Assessment Scale.
次要结局
- microRNA expression(up to 3 days post-operatively)
研究者
Ahmad Shabsigh
Assistant Professor
Ohio State University
