the Impact of Noise on Requirements of Anesthetics During General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia
研究概览
简要总结
The investigators hypothesize that the noise level in the operating theatre influences the patients' requirements of anesthetics. Study subject are patients undergoing abdominal surgery in combined general and epidural anesthesia. Analgesia is maintained by epidural injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the inhalational anesthetic desflurane. Desflurane requirements are adjusted using neuromonitoring (BIS-Index). Intraoperative noise levels are recorded. Patients are randomized to receive hearing protections or not.
详细描述
All patients receive standardized anesthesia and monitoring according to the usual clinical care in the department. Placement of epidural catheters takes place before induction of general anesthesia. Thereafter, 10 ml ropivacaine 0.3% with 10 µg sufentanil are administered epidurally every 60 min to induce and maintain analgesia during surgery.
Following induction of general anesthesia and tracheal Intubation, intraoperative hypnosis is maintained using desflurane.
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, Care Provider, 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
- 否
入选标准
- •full contractual capability
- •written informed consent
- •abdominal surgery in combined general/epidural anesthesia
- •position during surgery: supine
- •clinically normal hearing
排除标准
- •history of psychiatric disease
- •history of intraoperative awareness
- •clinically impaired Hearing
- •contraindication for placing an epidural catheter
结局指标
主要结局
Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia
时间窗: one hour
Aimed BIS-index is 50, desflurane is measured in expiratory volume percentage
次要结局
- Awareness Using a Structured Interview ("Modified Brice Questionnaire")(1 day)