Median Effective Dose of Ciprofol-Assisted Sedation for Elderly Patients Undergoing Knee Arthroplasty
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Modified Alertness Sedation Score (MOAA/S)
研究概览
简要总结
Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the median effective dose(ED50) of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia
详细描述
Select the patients who received knee arthroplasty in the Second Hospital of Shanxi Medical University. The patients received a loading dosage of 0.05mg/kg of ciprofol to begin sedation following the completion of intravertebral anesthesia, and the maintenance dose is calculated using the sequential method. Based on the relevant literature and pilot study, 0.2 mg·kg-1·h-1 is selected as initial test dose with a dose gradient of 0.02 mg·kg-1·h-1. The Modified Alertness Sedation Score (MOAA/S ) scores and the bispectral index (BIS) were recorded for patients before administration (T0), 5 min after administration (T1), 10 min after administration (T2), 20 min after administration (T3), 30 min after administration (T4), 45 min after administration (T5), and 60min after administration (T6). If the first patient had ≥ 4 time points with MOAA/A score ≤3 and BIS<85 from T0-T6, the sedation was regarded as satisfactory, then the next patient 's dose of ciprofol was reduced by one level. On the contrary, if the patient's MOAA/S score and BIS at T0-T6 had less than 4 points of MOAA/S ≤3 points and BIS <85, it was regarded as unsatisfactory sedation. The next patient's dose of ciprofol was increased by one level. After 8 crossovers, the trial was terminated. At the same time, the change of vital signs and adverse reactions before and after administration were recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •ASA grade I~III
- •BMI 18~30 kg/m2
排除标准
- •Contraindications to intrathecal anesthesia
- •Suffering from severe psychiatric or neurologic disorders or taking sedative drugs within the last 3 months
- •Difficult airway or having respiratory diseases such as upper airway obstruction
- •Severe cardiovascular system diseases
- •Severe hepatic or renal dysfunction
- •Allergy or contraindication to propofol and its drug-related components
- •Patient Prefusal
研究组 & 干预措施
ciprofol-assisted sedation 1
Adjusting the dose of ciprofol-assisted sedation in knee arthroplasty on a case-by-case basis
干预措施: Ciprofol (Drug)
结局指标
主要结局
Modified Alertness Sedation Score (MOAA/S)
时间窗: 24 hours
Changes in Modified Alertness Sedation Score
Bispectral index (BIS)
时间窗: 24 hours
Changes in Bispectral index
次要结局
- systolic blood pressure (SBP)(24 hours)
- diastolic blood pressure(DBP)(24 hours)
- heart rate (HR)(24 hours)
- pulse oxygen saturation(SpO2)(24 hours)
研究者
Zheng Guo
Professor
Second Hospital of Shanxi Medical University
