Randomized Controlled Trial of Epidural-General Anesthesia Versus General Anesthesia for Open Pancreaticoduodenectomy: Influence on Complications and Overall Two Year Survival
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 3
- 主要终点
- Number of Incidences of Grade 3 or Greater Complications
研究概览
简要总结
The purpose of this study is to see if there is a difference in complications in patients who have an epidural started earlier (during their surgery) and used as part of the anesthetic in addition to using it for post operative pain compared with patients who receive an epidural later in the surgery to be used only for post operative pain.
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
- Single (Investigator)
盲法说明
(surgical staff) blinded
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
- •Adult patients ≥ 18 years of age who can provide informed consent
- •Scheduled for pancreaticoduodenectomy
排除标准
- •Pregnancy
- •History of documented anaphylaxis or contraindication to any of the study medications
- •Significant cognitive impairment or documented psychologic impairment
- •Contraindication to epidural per Pain Service guidelines
- •Use of a sustained release opioid medication such as long-acting morphine, fentanyl patches, methadone, and buprenorphine within the last 3 months
- •Post randomization exclusion will occur if the patient is found to have unresectable disease at laparotomy and therefore will not have the potential for the same postoperative complications.
研究组 & 干预措施
Epidural-General Anesthesia
干预措施: Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml (Drug)
Epidural-General Anesthesia
干预措施: Open Pancreaticoduodenectomy (Procedure)
General Anesthesia
干预措施: Propofol+ Rocuronium+ Fentanyl + Inhalational (Drug)
General Anesthesia
干预措施: Open Pancreaticoduodenectomy (Procedure)
结局指标
主要结局
Number of Incidences of Grade 3 or Greater Complications
时间窗: 90 days post operatively
Complications will be graded in severity according to the MSKCC Graded Post Operative Complications Criteria based on the modified Dindo, Clavien classification of surgical complications, a grading system commonly used for this procedure.3,4 This classification grades complications from 1-5, with Grade 1 complications requiring bedside intervention. Grade 2 requires moderate interventions, such as intravenous medications. Grade 3 requires either a surgical, endoscopic or interventional radiology procedure for treatment. Grade 4 results in chronic deficit or disability. Grade 5 complications result in death.
次要结局
未报告次要终点