Bispectral Index Under Propofol Anesthesia in Children : a Comparative Randomised Study Between TIVA and TCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Percentage of time spent at adequate BIS values
研究概览
简要总结
In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI SBIS).
Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias and imprecision will be calculated.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •weighting more than 15 kg;
- •American Society of Anesthesiologists physical status I or II
- •scheduled for middle ear surgery
排除标准
- •cardiovascular, neurological, hepatic or renal impairment, if their body mass index was above 95th percentile or if they received any drug interfering with the central nervous system.
研究组 & 干预措施
TIVA0
Propofol : TIVA guided by clinical signs. Remifentanil
干预措施: Remifentanil (Drug)
TIVA BIS
propofol : TIVA guided by EEG Monitoring. Remifentanil
干预措施: EEG Monitoring (Device)
TIVA BIS
propofol : TIVA guided by EEG Monitoring. Remifentanil
干预措施: Remifentanil (Drug)
TCI KBIS
Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.
干预措施: EEG Monitoring (Device)
TCI KBIS
Propofol : TCI Kataria guided by EEG Monitoring. Remifentanil.
干预措施: Remifentanil (Drug)
TCI SBIS
Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.
干预措施: EEG Monitoring (Device)
TCI SBIS
Propofol : TCI Schnider guided by EEG Monitoring. Remifentanil.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Percentage of time spent at adequate BIS values
时间窗: from the beginning to the end of the anesthesia
次要结局
未报告次要终点
研究者
Pr Isabelle CONSTANT
Professor Isabelle Constant
Hôpital Armand Trousseau