A Comparison of Efficacy of Clinical Parameters With Auditory Evoked Potentials in Monitoring of Adequate Course of General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Changes in AAI values in selected (16) time points.
研究概览
简要总结
Clinical monitoring is the most common method of adjustment of the appropriate level of general anesthesia. However, the episodes of intraoperative awareness are still reported, suggesting that clinical observations may not be sufficient in some cases. The objective of the study was to compare the efficacy of clinical and instrumental neuromonitoring with auditory evoked potentials in intraoperative analysis of the proper level of general anesthesia.
The patients scheduled for elective surgery were included into the study, and randomly divided into two groups. Patients in the first group (TIVA group) underwent intravenous, in the second group (VA group) underwent volatile anesthesia. The adequacy of anesthesia was analyzed with standard clinical parameters. All the participants were instrumentally monitored with AAI index. After the anesthesia patients received a questionnaire with the questions regarding possible intraoperative awareness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
During the anesthesia, in all the participants an AAI-A line ARX index was continuously monitored. The electrodes were placed after the induction of anesthesia.
Intraoperatively, both auditory evoked potentials with AAI index and electroencephalogram with burst suppression analysis was recorded. Recorded data were blinded for anesthesiologists, so were not used for analysis of level of anesthesia during surgery.
入排标准
- 年龄范围
- 18 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients scheduled for ENT procedures or discectomy,
- •preoperative health status I or II according to ASA score.
排除标准
- •patients below 18 or above 61 year old,
- •ASA status III or higher,
- •patients suffering from: (i) hearing problems or tinnitus, (ii) chronic inflammation of the ear, (iii) epilepsy, and (iv) mental disorders,
- •pregnancy.
研究组 & 干预措施
TIVA group
The participants scheduled for elective ENT procedures or for elective discectomy. The surgery was performed under totally intravenous anesthesia.
During procedure, monitoring of the proper level of general anesthesia both clinical and instrumental was performed.
干预措施: monitoring of the proper level of general anesthesia (Other)
VA group
The participants scheduled for elective ENT procedures or for elective discectomy. The surgery was performed under volatile anesthesia. During procedure, monitoring of the proper level of general anesthesia both clinical and instrumental was performed.
干预措施: monitoring of the proper level of general anesthesia (Other)
结局指标
主要结局
Changes in AAI values in selected (16) time points.
时间窗: T1: after premedication, just before the onset of anesthesia; T2: 30 seconds after intravenous administration of propofol; T3: just before the endotracheal intubation; T4: 60 seconds after the endotracheal intubation; T5: 5 minutes after the endotracheal
次要结局
未报告次要终点
研究者
Dariusz Tomaszewski
Adjunct professor
Military Institute od Medicine National Research Institute