The BALANCED Anaesthesia Study A Prospective, Randomised Clinical Trial of Two Levels of Anaesthetic Depth on Patient Outcome After Major Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- One-year all-cause mortality
研究概览
简要总结
General anaesthesia is a reversible drug-induced coma. Too little can result in patients being partially conscious during surgery; too much can slow recovery after surgery. There is a range of drug doses that can be used and some anesthesiologists use more than others. There is no convincing evidence that any particular dose within the usual range is better. Consequently, there are no guidelines on the best depth of anaesthesia. This study will determine whether general anesthetic concentrations at the low end of the usual range are better than those at the high end.
Participants will randomly be assigned to lighter or deeper general anesthesia. The first day after surgery, two short questionnaires about recovery and memories of the surgery will be completed. During the rest of the participant's hospital stay, a survey about how one feels will be completed.
There will be two telephone contacts after discharge from the hospital. One month after surgery three questionnaires will be completed about performing daily tasks, how you feel and memories of the surgery. Then one year after surgery pain will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years
- •ASA physical status 3 or 4
- •surgery expected to last ≥2 hours
- •post-operative hospital stay expected to be ≥2 nights
- •general anaesthesia with or without major regional block
- •able to monitor BIS throughout anaesthesia
排除标准
- •Unable to monitor BIS (e.g. cranial or intracranial surgery)
- •unable to consent
- •surgery with 'wake-up' test
- •propofol infusion for part or all of maintenance of anaesthesia ('total intravenous anaesthesia')
- •previous enrolment in Balanced study
结局指标
主要结局
One-year all-cause mortality
时间窗: One year
次要结局
未报告次要终点
