Bispectral Index and Patient State Index During General Anesthesia With Remimazolam: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The percentage of time when bispectral index (BIS) was < 60
研究概览
简要总结
The aim of this study is to compare the bispectral index (BIS) and patient state index (PSI) during general anesthesia using remimazolam. The infusion rate of remimazolam is 6-12mg/kg/h during induction of anesthesia and 1-2mg/kg/h during maintenance of anesthesia. To calculate the fraction, the sum of times when BIS<60 and PSI <50 will be divided by the time from the loss of consciousness during induction of anesthesia to fully awake during emergence. We will compare the fraction of BIS <60 and the fraction of PSI <50 to find if there is some difference between the two depth of anesthesia monitoring devices during remimazolam anesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 19 years need general anesthesia
- •American Society of Anesthesiologists (ASA) Classification I, II
- •Written informed consent
排除标准
- •American Society of Anesthesiologists (ASA) Classification III, IV, V
- •BMI > 40kg/m^2
- •Past medical history of anaphylactic reaction to remimazolam, remifentanil, or other benzodiazepines.
- •Administration of anxiolytics, antipsychotics, rifampicin, succinylcholine, neostigmine, flumazenil, and cyclosporin within the past 24 hours
- •Benzodiazepine user (e.g. for seizure control)
- •Transfer to intensive care unit after surgery
结局指标
主要结局
The percentage of time when bispectral index (BIS) was < 60
时间窗: During anesthesia (up to 6hours)
The percentage of time when BIS was \< 60 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.)
The percentage of time when patient state index (PSI) was < 50
时间窗: During anesthesia (up to 6hours)
The percentage of time when PSI was \< 50 (divided by the time between the loss of consciousness during induction of anesthesia and the full awakening during emergence from anesthesia.)
次要结局
- Remifentanil infusion history(During anesthesia (up to 6hours))
- Total amount of remimazolam used (mg/kg/h)(During anesthesia (up to 6hours))
- Heart rate (bpm)(During anesthesia (up to 6hours))
- blood pressure (mmHg)(During anesthesia (up to 6hours))
- Bispectral index (BIS) during anesthesia(During anesthesia (up to 6hours))
- Patient state index (PSI) during anesthesia(During anesthesia (up to 6hours))
- The percentage of time when bispectral index (BIS) was < 60, and > 40.(During anesthesia (up to 6hours))
- The percentage of time when patient state index (PSI) was < 50, and > 25.(During anesthesia (up to 6hours))
- The last number patient remember that he/she spoke during induction of anesthesia(During anesthesia (up to 6hours))
- Remimazolam infusion history(During anesthesia (up to 6hours))
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital