Comparing Ciprofol and Propofol for Sedation in Hypotensive ICU Patients: a Single Center Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- The proportion of patients meeting the RASS sedation
研究概览
简要总结
This study was a single-center, prospective, 2-year observational cohort study. The study subjects were ICU patients requiring vasopressor drugs and requiring sedation. According to the use of ciprofol or propofol in the treatment plan (determined by the doctor in charge according to the condition of the subjects), they were divided into groups: ciprofol group and propofol group. A total of 456 subjects were planned to be enrolled, including 304 subjects in the cyclopofol group and 152 subjects in the propofol group. The data of this study were obtained by extracting the routine clinical diagnosis and treatment records of the enrolled subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18;
- •It needs to be treated with vasopressors to maintain mean arterial pressure ≥65 mmHg;
- •Sedative medication required for comfort, safety, and to facilitate life support measures;
- •Obtain the informed consent of the human subjects or their legal representatives.
排除标准
- •Pregnant patient;
- •Patients with proven acute severe intracranial or spinal neurological disease due to vascular, intracranial dilatation, or injury;
- •History of allergy to cyclopofol, propofol, eggs, or soy products;
- •History of long-term use of benzodiazepines or opioids;
- •Sedative drugs other than propofol or cyclopofol were used at enrollment, or propofol and cyclopofol were used alternately within 24 hours;
- •The researchers judged that they are not suitable to participate in this study.
研究组 & 干预措施
ciprofol group
Hypotensive ICU patient sedated with ciprofol
干预措施: ciprofol (Drug)
结局指标
主要结局
The proportion of patients meeting the RASS sedation
时间窗: within 24 hours
Professionally trained researchers perform RASS scores on patients at specific time points
次要结局
- Dosage of norepinephrine during sedation (total dose/time of use)(up to 24 hours)
- Dosage of propofol or ciprofol during sedation (total dose/time of use)(up to 24 hours)
- Duration of mechanical ventilation(From endotracheal intubation to withdrawal from mechanical ventilation,up to 28 days)
- length of ICU stay(up to 28 days)
- The mortality rate(up to 28 days)
- Incidence of adverse events(up to 3 days)