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临床试验/NCT03928236
NCT03928236进行中(未招募)不适用

Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

Population Health Research Institute40 个研究点 分布在 2 个国家目标入组 15,886 人开始时间: 2019年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
15,886
试验地点
40
主要终点
Incidence of Delirium

研究概览

简要总结

B-FREE is a pragmatic, multicentre, cluster crossover trial evaluating whether a policy limiting the use of intra-operative benzodiazepine reduces post-operative delirium when compared with a policy of 'ad libitum' administration. The knowledge generated by this study will provide the basis for cardiac anesthesia practice guidelines.

详细描述

Delirium, an acute state of confusion, occurs in approximately 1 in 5 adults after open heart surgery. Even though it is a temporary state, patients who experience delirium are at increased risk of serious problems that last after the delirium has resolved. These problems include decreases in thinking, mobility, self-care, and the ability to live independently in a community setting. Patients who experience delirium have longer stays in hospital, are more likely to be discharged to a nursing home, and are more likely to die. Benzodiazepines are a sedative and amnestic medication that may be associated with delirium. As such, benzodiazepines are rarely used for sedation in the intensive care unit after cardiac surgery. However, benzodiazepines continue to be used frequently in the operating room by anesthesiologists during open heart surgery because of their amnestic effects and limited impact on blood pressure. Nevertheless, practice is divided among cardiac anesthesiologists, with some never using benzodiazepines and others using them for nearly all patients.

Because the best approach (routine benzodiazepines or restricted benzodiazepines) remains uncertain, we will compare the effect of a hospital policy of intraoperative medication use that includes benzodiazepines to a policy that uses alternative medications and no benzodiazepines on the incidence of delirium after open heart surgery. The findings of the study have the potential to improve the outcomes of tens of thousands of patients around the world and will provide the basis for cardiac anesthesiology practice guidelines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

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

  • Hospital is a major surgical center with a minimum of 250 cases of cardiac surgery per year.
  • Equipoise by the hospital physicians regarding the use of benzodiazepines during surgery (≥ 95% of hospital cardiac anesthesia group agrees to manage adult patients (age >18 years) as per the benzodiazepine policy in place during a given crossover period).
  • Hospital routinely assesses patients (age >18 years) for postoperative delirium at least once every 12 hours during the initial 72 hours after cardiac surgery as a part of routine clinical care using either the Confusion Assessment Method-ICU (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC).

排除标准

  • Hospital does not meet inclusion criteria

结局指标

主要结局

Incidence of Delirium

时间窗: up to 72 hours post cardiac surgery

Delirium assessed up to 72 hours after surgery using standardized and validated delirium scales

次要结局

  • Number of Days in ICU after Cardiac Surgery(through study completion, approximately 37 months)
  • Number of Days in Hospital after Cardiac Surgery(through study completion, approximately 37 months)
  • Incidence of In-hospital Mortality(through study completion, approximately 37 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (40)

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