Prospective Evaluation of Volatile Sedation With Regard to Awakening Behaviour and Extubation Capacity in Patients Undergoing Heart Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time to extubation
研究概览
简要总结
Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids.
The study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Valve reconstruction or valve replacement
- •Must be capable to giving written consent
排除标准
- •Intolerance to volatile anaesthetics (e.g. malignant hyperthermia)
- •Severe obstructive pulmonary disease
- •Extended aortic arch or ascending aorta surgery
- •Age <18 years
结局指标
主要结局
Time to extubation
时间窗: through study completion, an average of 2 days
Time from admission on ICU until awakening and Extubation.
次要结局
- Factors related to the course of operative procedure(through study completion, up to 24 hours)
- Factor related to the course of intensive care: kidney injury(through study completion, an average of 24 hours)
- Factor related to the course of intensive care: blood loss(through study completion, an average of 24 hours)
- Factor related to the course of intensive care: acid-base balance(through study completion, an average of 24 hours)
- Factor related to the course of intensive care: lung function parameters(through study completion, an average of 24 hours)
- Factor related to the course of intensive care:cardiovascular medication(through study completion, an average of 24 hours)
- Time to neurocognitive assessability(through study completion, an average of 2 days)
- Required setup time of the intensive care workplace(through study completion, up to 24 hours)
- Intra-hospital mortality(through study completion, an average of 7 days)
- Liver failure(through study completion, an average of 7 days)
- postoperative nausea and vomiting(through study completion, up to 24 hours)
研究者
Armin N. Flinspach
Principal Investigator
Goethe University