NCT07092384已完成不适用
Effect of Remifentanil on Pruritus and Paresthesia Caused by Fospropofol Disodium Anesthesia
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Incidence of pruritus and paresthesia after administration of fospropofol disodium
研究概览
简要总结
Explore the effect of remifentanil on pruritus and paresthesia induced by fospropofol disodium in adults
详细描述
Explore the effect of remifentanil on pruritus and paresthesia caused by fospropofol disodium in adults, to observe the manifestations and duration of pruritus and paresthesia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old, plans to undergo elective non-cardiac surgery under general anesthesia.
- •ASA I-II;
- •The operation duration > 30 min;
- •BMI 18-30kg /m2；
- •Sign the informed consent form.
排除标准
- •history of drug abuse or alcohol dependence;
- •used sedative or analgesic drugs before operation;
- •with severe liver and kidney function impairment;
- •allergic to propofol and lipids;
- •surgery that directly affect hemodynamics with surgical operations, such as macrovascular surgery;
- •abnormal coagulation function, endocrine diseases or other effects on hemodynamic status;
- •Participation in other clinical researchers in the past 3 months
研究组 & 干预措施
Group R1
Experimental
remifentanil 0.5μg/kg
干预措施: Remifentanil (Drug)
Group R2
Experimental
remifentanil 1.0μg/kg
干预措施: Remifentanil (Drug)
Group R3
Experimental
remifentanil 1.5μg/kg
干预措施: Remifentanil (Drug)
Group R4
Experimental
remifentanil 2.0μg/kg
干预措施: Remifentanil (Drug)
Group S
Active Comparator
sufentanil 0.3μg/kg
干预措施: Sufentanil (Drug)
结局指标
主要结局
Incidence of pruritus and paresthesia after administration of fospropofol disodium
时间窗: 24 hours
Observe the incidence of pruritus and paresthesia in patients within 3 minutes after administration
次要结局
- Time of pruritus or paresthesia(1 day)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 day)
- dosage of drugs(1 day)
- time records checklist(1 day)
- duration of pruritus or paresthesia(24 hours)
研究者
研究点 (1)
Loading locations...
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