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临床试验/NCT03132168
NCT03132168已完成不适用

Postoperative Delirium in Patients Undergoing Radical Cystectomy

Ohio State University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月10日最近更新:
适应症

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

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

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

Ahmad Shabsigh

Assistant Professor

Ohio State University

研究点 (2)

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