Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- reduction of awareness
研究概览
简要总结
This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.
详细描述
Awareness is possible in TIVA in case of technical failure or prolonged induction phase, TCI technology seems to prevent these events. Total of 80 patients planed for elective neurosurgical brain tumor resection fulfilling the inclusion criteria will be devided into two groups. First half will be anesthetized using TIVA with manual induction and the second half will be anesthetized using TCI. All patients will fulfil Modified Brice Questionnaire one hour after the end of operation.
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
- 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
- •Glasgow Coma scale 15
- •ASA Physical Status Classification System I - III
- •planed surgery for brain tumor to 5 hours
- •postoperative awakening
排除标准
- •NYHA III, IV
- •abuse of stimulating drugs, grass, alcohol dependence
- •BMI over 40 in females and over 35 in men
- •propofol alergie
- •awake operations
- •postoperative arteficial ventilation
结局指标
主要结局
reduction of awareness
时间窗: 5 hours
consciousness during operation
次要结局
- reduction of haemodynamical instability(5 hours)
- reduction of norepinephrine dose(5 hours)
研究者
Dostalova Vlasta, MD, PhD
Principal Investigator
University Hospital Hradec Kralove