NCT02742012已完成不适用
A Multicenter Validation Study of a Multimodal Indicator of Anesthesia Calculated From the Electroencephalogram and Standard Monitoring Parameters
Technical University of Munich3 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 257
- 试验地点
- 3
- 主要终点
- ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness
研究概览
简要总结
The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28).
The indicator previously developed shall now be tested on an independent set of data.
The investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers.
The design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age ≥ 18 years
- •elective surgery under general anesthesia
- •anticipated operating time of about one hour or longer
- •ASA physical status I-III
- •written informed consent
排除标准
- •chronic intake of CNS affecting drugs
- •alcohol or drug abuse in the last three months
- •CNS or psychiatric disease
- •hardness of hearing or deafness
- •abnormal gastrointestinal motility
- •non-adherence to fasting guidelines, emergency surgery
- •anticipated difficult airway
- •pregnancy
- •cardiac surgery and surgery involving the head and/or neck
- •postoperatively prolonged intubation
- •pre- and/or postoperative intensive care treatment
结局指标
主要结局
ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness
时间窗: 1 minute
次要结局
- the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia(1 minute)
研究者
Andreas Ranft
Dr. med.
Technical University of Munich
研究点 (3)
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