95% Effective Dose (ED95) of Fospropofol Disodium for Adjunctive Sedation During Spinal Anesthesia in Elderly Patients Undergoing Lower Extremity Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 95% Effective Dose (ED95) of Fospropofol Disodium for Sedation in Elderly Patients Undergoing Lower Extremity Surgery with Spinal Anesthesia
研究概览
简要总结
This study aims to determine the 95% effective dose (ED95) of fospropofol disodium, a new sedative drug, for adjuvant sedation during spinal anesthesia in elderly patients (aged 65 years and older) undergoing lower extremity surgery (e.g., hip/knee replacement, lower limb fracture fixation).
详细描述
Fospropofol disodium, the only water-soluble propofol prodrug marketed in China, features mild effects on respiratory and circulatory systems, low injection pain, no lipid metabolism-related adverse reactions, and suitable duration of action-making it a promising sedative for elderly patients. However, clinical data on its use in adjuvant sedation during spinal anesthesia are lacking, with no reports on its effective dose in this specific scenario. This prospective sequential trial aims to determine the 95% effective dose (ED95) of fospropofol disodium for sedation induction and maintenance in elderly patients (≥65 years) undergoing lower extremity surgery with spinal anesthesia, providing evidence-based guidance for safe and rational clinical use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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, no gender restriction
- •Scheduled for elective lower extremity surgery with spinal anesthesia
- •ASA physical status classification Ⅰ-Ⅲ
- •BMI 18.5-28.0
- •Written informed consent obtained from patients or their guardians
排除标准
- •Age <65 years；
- •Non-lower extremity surgery or conversion to general anesthesia；
- •ASA physical status classification Ⅳ or above；
- •BMI <18.5 or >28.0；
- •History of drug abuse or alcohol dependence；
- •Preoperative use of sedative or analgesic drugs；
- •Refusal to participate or inability to sign informed consent；
- •Severe arrhythmia or myocardial infarction within 3 months；
- •Severe liver or kidney dysfunction；
- •Severe respiratory diseases；
- •Coagulopathy；
- •Uncorrected severe electrolyte disturbance；
- •History of mental illness or cognitive impairment.
研究组 & 干预措施
Fospropofol Disodium - Sedation ED95 Exploration
This arm aims to explore the 95% effective dose (ED95) of fospropofol disodium for sedation in elderly patients undergoing lower extremity surgery with spinal anesthesia.
干预措施: Fospropofol Disodium (Drug)
结局指标
主要结局
95% Effective Dose (ED95) of Fospropofol Disodium for Sedation in Elderly Patients Undergoing Lower Extremity Surgery with Spinal Anesthesia
时间窗: ① Induction ED95: Assessed at 3 minutes after completion of the fospropofol disodium induction bolus; ② Maintenance ED95: Assessed throughout the intraoperative maintenance phase (6 evaluations, 10 minutes apart).
The primary outcome is the 95% effective dose (ED95) of fospropofol disodium for adjuvant sedation during spinal anesthesia in elderly patients (≥65 years), including two key components: ① Induction ED95: The intravenous bolus dose at which 95% of patients achieve a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤3 within 3 minutes of administration (dose range: 4.0-8.0mg/kg, gradient: 0.5mg/kg); ② Maintenance ED95: The continuous intravenous infusion rate at which 95% of patients maintain an MOAA/S score ≤3 in ≥4 out of 6 intraoperative assessments (performed every 10 minutes) after successful induction (rate range: 3.0-7.5mg/kg/h, gradient: 0.5mg/kg/h). Both ED95 values (and their 95% confidence intervals \[CI\]) will be calculated using Probit regression analysis, with sedation success (effective=1, ineffective=0) as the dependent variable and dose/rate as the independent variable.
次要结局
- Induction Onset Time of Fospropofol Disodium(From the start of fospropofol disodium bolus injection to the first achievement of MOAA/S score ≤3, assessed up to 5 minutes.)
- Recovery Time After Sedation Maintenance Discontinuation(From the moment of maintenance infusion cessation (start of surgical skin closure) to the time when MOAA/S score returns to 5, assessed up to 30 minutes.)
- Incidence of Respiratory Depression(Throughout the sedation period (from induction drug injection to maintenance infusion cessation) and within 10 minutes postoperatively.)
- Intraoperative Changes in Mean Arterial Pressure (MAP)(Baseline (pre-sedation), 1/3/5 min post-induction, and every 10 minutes during maintenance.)
- Intraoperative Changes in Heart Rate (HR)(Baseline (pre-sedation), 1/3/5 min post-induction, and every 10 minutes during maintenance.)
- Incidence of Postoperative Adverse Reactions(Within 24 hours postoperatively (assessed during ward rounds or follow-up).)
研究者
Ya-Qun Zhou
Associate Professor
Tongji Hospital