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临床试验/NCT02692300
NCT02692300已完成不适用

Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES-CANADA) Study: a Pragmatic, Randomized Clinical Trial

University of Manitoba2 个研究点 分布在 1 个国家目标入组 1,225 人开始时间: 2016年12月28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
1,225
试验地点
2
主要终点
Incidence of post-operative delirium

研究概览

简要总结

This study examines the potential link between deep levels of anesthesia and delirium.

详细描述

ENGAGES CANADA is a parallel study to the ENGAGES study which has been published in JAMA, DOI:10.1001/jama.2019.5161. Due to the difference in practice models and types of anesthesia principles, ENGAGES CANADA is an important study. Delirium is a relatively common postoperative complication in the geriatric population, affecting 20% to 70% of surgical patients over the age of 60. Delirium manifests as confusion, inattention and the inability to think logically, and may affect the patient's postoperative healing and rehabilitation. It is associated with persistent cognitive decline, longer hospital stay, increased incidence of injurious falls, and increased mortality. Patients undergoing major cardiac surgery are at a significant risk of postoperative delirium. To date, there is no proven method to prevent postoperative delirium in this patient population and often delirious events remain unrecognized. Randomized controlled studies in diverse surgical patient populations suggest that intraoperative electroencephalography (EEG) guidance during general anesthesia may decrease postoperative delirium and adverse postoperative outcomes. Patients who experience postoperative delirium report persistently decreased quality of life and it is a risk factor for incident psychiatric disorders and psychotropic medication use. One potential key mechanism in the relationship between delirium and incident psychiatric illness may be the experience of dissociation (disturbed awareness, impaired memory, or altered perceptions) in the perioperative period in those who are delirious. The co-occurrence of psychiatric illness and delirium can put older adults at greater risk of negative long terms effect such as functional decline. This study will compare the effectiveness of two anesthetic protocols in reducing postoperative delirium and postoperative health-related quality of life in a high risk population.We expect that EEG-guided anesthetic management of patients during their operative procedure will result in improved health-related outcomes, specifically decreased incidence of postoperative delirium and improved postoperative mental and physical health outcomes.

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
Double (Participant, Investigator)

盲法说明

Anesthesia practitioner is not blinded to intervention. Subject is blinded and primary outcome assessor is blinded to intervention.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 60 years or older;
  • Competent to provide informed consent;
  • Undergoing elective cardiac surgery requiring cardiopulmonary bypass.

排除标准

  • Unable to provide informed consent;
  • Preoperative delirium;
  • Unable to participate adequately in delirium screening including those who are blind, deaf, illiterate or not fluent English or French;
  • History of intraoperative awareness

结局指标

主要结局

Incidence of post-operative delirium

时间窗: 5 days

Incidence of delirium will be compared between the Control Group and the EEG-Guided Group as measured by the numbers of positive Confusion Assessment Method (CAM) or CAM for intensive care unit (CAM-ICU) scores, coupled with Chart Review.

次要结局

  • Length of ICU stay(Time (days) in ICU from Post-Operative Day (POD) 1 to 5 (or through study completion at one year))
  • Length of Hospital stay(Time (days) from admission to discharge from hospital (or through study completion at one year))
  • Incidence of mortality at 30 days and at 1 year(30 days, 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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EEG Guidance of Anesthesia (ENGAGES-CANADA) | 临床试验