Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation in Anesthesiology Intensive Care Unit: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions
研究概览
简要总结
The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:
- Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).
- Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.
- Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.
Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years old
- •Intubation and mechanical ventilation <12h before enrollment
- •Expected to require continuous invasive ventilation and sedation less than 6h after admission to anesthesia intensive care unit (AICU).
- •Signed informed consent
排除标准
- •parturient, childbirth or lactating mothers
- •acute severe neurological disease or coma
- •chronic renal failure
- •previous mechanical ventilation >12h
- •severe liver dysfunction (Child-Pugh score C)
- •BMI >30kg/m2 (>90kg)
研究组 & 干预措施
Fospropofol group
Fospropofol is administered to patients after admission to the roomat a pumping rate of 1 mg/kg/h.
干预措施: Fospropofol (Drug)
Propofol group
Propofol is administered after admission to the room at a pumping rate of 0.5 mg/kg/h.
干预措施: Fospropofol (Drug)
结局指标
主要结局
The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions
时间窗: Admission to the intensive care unit to 2 hours after weaning off the ventilator.
The participant's RASS score was assessed by the caregiver and the occurrence of adverse reactions was recorded. Adverse effects include hypotension, bradycardia, tachycardia, agitation, pain at the injection site, nausea and vomiting, edema, fever, anemia, paresthesias, headache, and hypoxemia.
次要结局
- Incidence of adverse reactions during the follow-up period(2 hours after weaning off the ventilator to 24 hours after leaving the intensive care unit.)
- Extubation time(From admission to the intensive care unit to removal of the endotracheal tube)