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临床试验/NCT02119806
NCT02119806撤回4 期

Decreasing the Incidence of Delirium After Cardiac Surgery

University of California, Los Angeles1 个研究点 分布在 1 个国家开始时间: 2017年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Delirium

研究概览

简要总结

In critically ill surgical patients, delirium (confusion and disorientation) is extremely common and is associated with longer hospital length of stay, mortality, cost, and long term cognitive impairment. The goal of the study is to establish whether benzodiazepines (a sedative, anti-anxiety drug) should be used as part of standard of care or be eliminated by comparing the chances of delirium in cardiac surgery patients between two groups: a group that receives benzodiazepines during surgery versus a group that does not receive benzodiazepines during surgery. Benzodiazepines have historically been used in cardiac anesthesia to decrease the risk of anesthesia awareness. The current standard of care is to keep the patient on inhaled anesthesia throughout the surgery which eliminates the need for intraoperative use of benzodiazepines. Benzodiazepines are still used based on practitioner preference. Findings of this study will allow all anesthesiologists to make more informed decisions about what level of care our patients need.

详细描述

In critically ill surgical patients, delirium is extremely common and is associated with longer hospital length of stay, mortality, cost, and long term cognitive impairment. Benzodiazepine usage is common in anesthetic practice, and ICU literature demonstrates that limiting post-operative benzodiazepines decreases the incidence of delirium. However, the avoidance of preoperative and intraoperative benzodiazepines during cardiac surgery has not been studied in terms of its effect on delirium. The goal of the study is establish whether benzodiazepines should be used as part of standard of care or be eliminated by comparing the incidence of delirium in cardiac surgical patients when randomized to a group that receives benzodiazepines versus a group that does not receive benzodiazepines.

Potential subjects will be identified and recruited the day before surgery by primary investigators. Patients undergoing coronary artery bypass grafting or single valve procedures that consent to participate will be enrolled in the study. These patients may be consented during the pre-operative period. Patients will be informed that whether they enroll in the study or not, they will be receiving standard clinical care. Only subjects meeting all inclusion criteria and requirements for continuation in the study will be consented.

Patient will be randomized by age (age is a predictor of delirium) to 3 groups:

  • >80 years of age;
  • 70-80 years of age;
  • < 70 years of age.

Within these 3 groups, patients will be randomized to receive benzodiazepines during cardiac surgery or not. The anesthesiologist in the operating room will not be blinded to the group; however, the intensive care physician evaluating for delirium will be blinded to the treatment groups.

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, Outcomes Assessor)

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

  • Adult patients' undergoing coronary artery bypass grafting or single valve procedures.

排除标准

  • Patients who have baseline cognitive dysfunction,
  • Patients with hearing problems,
  • Patients currently on benzodiazepines

研究组 & 干预措施

Benzodiazepine group

Active Comparator
  1. Premedication 0.02mg/kg-0.1mg/kg of Benzodiazepine ;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol

干预措施: Benzodiazepine (Drug)

Benzodiazepine group

Active Comparator
  1. Premedication 0.02mg/kg-0.1mg/kg of Benzodiazepine ;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol

干预措施: Fentanyl (Drug)

Benzodiazepine group

Active Comparator
  1. Premedication 0.02mg/kg-0.1mg/kg of Benzodiazepine ;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol

干预措施: Propofol (Drug)

Non-benzodiazepine group

Active Comparator
  1. Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol

干预措施: Fentanyl (Drug)

Non-benzodiazepine group

Active Comparator
  1. Premedication 0-50mg of propofol and/or 0-250mcg of fentanyl;
  2. Maintenance 0.8 minimum alveolar concentration of inhaled anesthetic (MAC) and 10-30mcg/kg of fentanyl;
  3. Postoperative 10-100mcg/kg/min of propofol

干预措施: Propofol (Drug)

结局指标

主要结局

Delirium

时间窗: less than 2 minutes

Delirium can now be reliably diagnosed by non-psychiatrists in critically ill patients in less than 2 minutes through the use of validated monitoring instruments such as the Confusion Assessment Method for the ICU (CAM-ICU)

次要结局

未报告次要终点

研究者

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

Jacques Neelankavil

HS Assistant Clinical Professor

University of California, Los Angeles

研究点 (1)

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