A Prospective Randomized Controlled Trial on the Patient's Satisfaction of Bispectral Index-guided Monitored Anesthesia Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Iowa Satisfaction with Anesthesia Scale(ISAS)
研究概览
简要总结
The investigators will evaluate the effect of bispectral index-guided titration of sedation during ear surgery under monitored anesthesia care on participant's satisfaction with anesthesia, as well as side effects caused by the anesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The person who surveys the patient's satisfaction in the post anesthesia care unit does not know which group the patient was assigned to.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving ear surgery with ASA physical status 1 or 2
排除标准
- •Age under 19 years
- •Pregnancy
- •Cognitive disorder affecting daily activity
- •Patients who cannot participate in the survey
- •Allergy to the medication
- •History of sedative abuse
研究组 & 干预措施
OAA/S
The patients in the control group will receive MAC titrated according to observer's assessment of anesthesia/sedation(OAA/S) score.
干预措施: Titration under the guidance of OAA/S (Diagnostic Test)
BIS
The patients in the control group will receive MAC titrated according to bispectral index(BIS).
干预措施: Titration under the guidance of BIS (Device)
结局指标
主要结局
Iowa Satisfaction with Anesthesia Scale(ISAS)
时间窗: within 30 minutes after the end of surgery (in the PACU)
Patient's satisfaction with MAC
次要结局
未报告次要终点
研究者
Ho Geol Ryu
Assistant professor
Seoul National University Hospital