NCT03034096已完成4 期
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,826
- 试验地点
- 5
- 主要终点
- All-cause mortality
研究概览
简要总结
This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures:
- •Lobectomy or pneumonectomy
- •Esophagectomy
- •Radical (total) cystectomy
- •Pancreatectomy
- •Partial hepatectomy
- •Hyperthermic intraperitoneal chemotherapy (HIPEC)
- •Gastrectomy (subtotal or total)
- •Cholecystectomy or bile duct resection
排除标准
- •Age less than 18 years
- •American Society of Anesthesiologist Class 5
- •Projected life expectancy less than 30 days
- •Known or suspected hypersensitivity to either propofol, e.g. egg or soy allergy, or volatile general anesthetic agents
- •Known or suspected history of malignant hyperthermia
研究组 & 干预措施
Propofol infusion
Experimental
Maintenance of general anesthesia with propofol infusion
干预措施: Propofol (Drug)
Volatile agent
Experimental
Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
干预措施: Volatile Agent (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 2 year minimum
Time to event
次要结局
- Recurrence free survival(Minimum 2 years)
- All-cause mortality as a binary outcome(2 years)
研究者
Elliott Bennett-Guerrero
Professor and Vice Chairman
Stony Brook University
研究点 (5)
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