A Pilot Study to Determine the Outcomes of an Intraoperative Bispectral Index Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- BIS values
研究概览
简要总结
This pilot study is being conducted to determine whether the intraoperative presence of a Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in adult and pediatric studies it has been shown to decrease time to emergence, decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters, when BIS is present but not specifically designated to be used as a monitor to guide anesthesia delivery, has not been specifically examined. This will be the first pediatric study which applies BIS on all patients and randomizes the anesthesiologists to either be or not be privy to seeing the BIS values during intra-operative period.
详细描述
The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. In adult and pediatric studies, the BIS monitor has been shown to decrease time to emergence, decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters, when BIS is present but not specifically designated to be used as a monitor to guide anesthesia delivery, has not been specifically examined. This will be the first pediatric study which applies BIS on all patients and randomizes the anesthesiologists to either be or not be privy to seeing the BIS values during intra-operative period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •orthopedic or urologic day surgery
- •2 to 12 years old
排除标准
- •anesthesiologist refusal
- •patient/parent refusal
- •allergy to the BIS adhesive
- •history of seizures
结局指标
主要结局
BIS values
时间窗: intraoperative period
Compare the BIS values in the BISblind and BISvisible groups
次要结局
- Amount of intravenous anesthetic medications administered(intraoperative period)
- Pain scores(post operative period, until discharge from recovery room, assessed up to 10 hours)
- Time to meet discharge criteria(post operative period, until discharge from recovery room, assessed up to 10 hours)
- End tidal sevoflurane values(intraoperative period)
- Agitation/delirium(post operative period, until discharge from recovery room, assessed up to 10 hours)
研究者
Keira Mason
principal investigator
Boston Children's Hospital