Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Proportion participating
研究概览
简要总结
To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.
详细描述
Two-center single-blinded randomized feasibility study, with randomization 1:1 to either propofol TIVA or inhaled volatile general anesthesia for patients who are receiving elective non-cardiac surgery. Patients will be stratified by clinical site with 150 participants per site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •18 years or older
- •Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device)
排除标准
- •Inability to provide informed consent in English
- •Pregnancy (based on patient report or positive test on the day of surgery)
- •Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
- •Contraindication to propofol TIVA or inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)
- •Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring).
- •Hospital approved, written protocol mandating a particular technique
- •History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent
- •Planned postoperative intubation
结局指标
主要结局
Proportion participating
时间窗: 8 months
Proportion of patients who are approached to participate by the study team and who consent to participate in the study.
Proportion receiving inhaled anesthesia
时间窗: 8 months
Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).
Proportion receiving TIVA
时间窗: 8 months
Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).
次要结局
- Completeness of data collection(11 months)
研究者
Michael Avidan
Prof of Anesthesiology
Washington University School of Medicine