The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer
研究概览
简要总结
Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery.
As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered.
Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.
详细描述
Main goals
- Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia
- Evaluation of the effect of lidocaine infusion associated with TIVA/sevoflurane on the incidence of chronic pain and of cancer recurrences and survival.
Secondary objectives
- Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer
- Evaluation of the influence of lidocaine on postoperative inflammatory response
- Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Elective surgery
排除标准
- •• persistent chronic pain
- •chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
- •Contraindications for any of the study medications
- •Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.)
- •Significant hepatic (ALAT and/or ASAT > 2 normal values) or renal (plasma creatinine > 2 mg/dl) disorders
- •Convulsive disorders requiring medication during the last 2 years
- •Planned regional analgesia/anesthesia (spinal or epidural)
- •Corticoid dependent asthma
- •Autoimmune disorders
- •Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
- •Refusal for study participation
研究组 & 干预措施
TIVA + lidocaine
TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion.
Interventions: TIVA+lidocaine
干预措施: TIVA+lidocaine (Drug)
TIVA+placebo
TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)
干预措施: TIVA+placebo (Drug)
Sevoflurane+placebo
Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo).
Intervention: sevoflurane anesthesia +placebo (saline infusion)
干预措施: Sevoflurane+placebo (Drug)
Sevoflurane+lidocaine
Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively.
Intervention: sevoflurane anesthesia+ lidocaine infusion
干预措施: Sevoflurane+lidocaine (Drug)
结局指标
主要结局
Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer
时间窗: 5 years
Survival at 5 years will be recorded
Incidence of recurrences:
时间窗: 5 years
The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients.
次要结局
- Resumption of bowel function(0-72 h)
- Rate of postoperative complications after intravenous lidocaine infusion versus placebo(0-30 days)
- Morphine consumption during the first 24 postoperative hours(0- 24 h)
- Postoperative chronic pain(1 year)
- Postoperative imflamation(Day 1)
- Length of hospital stay(0-10 days)
- Rate of postoperative complications after TIVA versus inhalation anaesthesia(0-30 days)
- Severity of postoperative pain - verbal response pain (VRPS) score 1-10, (1=no pain, 10=worst pain) in recovery room and during the first 48 hrs postoperatively. Target verbal response pain score ≤3(0- 48 h)
研究者
Prof.Dr.Daniela Ionescu
Professor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor