NCT00181051暂停3 期
Clinical Utility of the Alaris MidLatencyAuditoryEvoked Potentials Monitor to Titrate the Anesthetic-Hypnotic Component of Anesthesia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Influence of AEP guided anesthesia on recovery delay
研究概览
简要总结
Index computed in real time from Auditory Evoked Potentials have been described parallel to depth of anesthesia. The goal of the study was to compare general anesthesia guided on Auditory Evoked Potentials monitoring to standrad practice in order to assess if AEP monitoring can improve recovery delay (main criteria) or intraoperative hemodynamic stability (secondary criteria). Patients were randomized in 2 groups, stratified by center. Group I : AEP guided anesthesia, Group II: Blind AEP record, standard practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA status I-II patients
- •aged 18 - 65 years
- •scheduled for general surgery (except laparoscopic interventions) lasting longer than 1 hour.
排除标准
- •Body weight < 70% or > 150% ideal body weight
- •neurological disorder and hearing disorders (being not able to communicate with the patient in a normal tone)
- •use of any medication interfering with pharmacological effect of the study including alcohol misuse or drugs.
结局指标
主要结局
Influence of AEP guided anesthesia on recovery delay
次要结局
未报告次要终点
研究者
研究点 (2)
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