The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- The value of the Wavelet index (WLi) when MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤ 1.
研究概览
简要总结
To explore the sedative effect of remimazolam in patients undergoing spinal anesthesia without pain stimulation. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
详细描述
Patients undergoing spinal anesthesia were received remimazolam besylate for sedation continuously. Both the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) and the Wavelet index (WLi) were used to monitor the depth of anesthesia of remimazolam, and exploring the correlation and consistency between MOAA/S score and WLi value at the same time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA was classified as I-III
- •The operation time was less than 120 minutes
- •Informed consent is signed by all study participants
- •Elective lower extremity surgery under spinal anesthesia was performed
排除标准
- •Pregnant or lactating women
- •Patients with Difficult Airways
- •History of severe neurological and muscular diseases and mental retardation
- •Patients with severe respiratory and circulatory diseases, including acute heart failure. Unstable angina pectoris. Resting ECG heart rate <50 beats/min. QTc: ≥470ms in men and ≥480ms in women. Third degree atrioventricular block. Severe arrhythmia. Moderate to severe heart valve disease. Chronic obstructive pulmonary disease. A history of severe asthma.
- •Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range
- •Take diazole drugs and/or opioids in one month or nearly three months
- •Patients who were allergic to or contraindicated to benzodiazepines, opioids, propofol, flumazenil, naloxone, etc
- •Patients who could not monitor the depth of anesthesia for various reasons
研究组 & 干预措施
Remimazolam group
Thirty patients underwent elective lower extremity surgery receive spinal anesthesia, and then, remimazolam besylate was given intravenously with an induction dose of 3mg/min. When the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score was ≤1, remimazolam besylate was maintained at 1mg/min for 24min, and finally stopped. Wavelet index, MOAA/S score, blood pressure, heart rate, respiratory rate, and pulse oxygen saturation were continuously monitored during the period.
干预措施: Remimazolam besylate (Drug)
结局指标
主要结局
The value of the Wavelet index (WLi) when MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤ 1.
时间窗: Through study completion, an average of 1 day
Sedation was assessed using the MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scale. It ranges from 5(alert) to 0(deep sedation). Wavelet index (WLi) is a parameter that potentially could be used to regulate the sedative depth of anesthesia. The range of WLi values is 0-100, with a value of 0 indicating no EEG activity, a value of 100 indicating complete wakefulness, and a value of 40-60 taken to indicate an appropriate level of general anesthesia.
次要结局
- Mean time from initiation of drug administration to MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score ≤1(Through study completion, an average of 1 day)
- The average time from drug withdrawal to full recovery(Through study completion, an average of 1 day)