Contributions to the Elucidation of the Mechanisms and Effects by Which Certain Perianesthetic Interventions Modify Long-term Evolution of Patients With Digestive Cancers Subjected to Surgery
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of the antiproliferative and apoptotic effects of anesthetic agents
研究概览
简要总结
Digestive cancers (liver, colonic, pancreatic) have a high incidence and high mortality, their population prevalence is also increasing. Given that the anesthesia techniques and the agents used act directly and indirectly on the immune system during the perioperative period, influencing both the treatment and the prognosis of patients with colorectal cancer who undergo elective interventions, a series of perianesthetic interventions have been proposed in order to reduce morbidity-mortality perioperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
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
- 是
入选标准
- •18 to 80 years old patients admitted for elective colorectal surgery
排除标准
- •Pre-existing chronic pain
- •Chronic medication that may interfere with pain: antiepileptics, NSAIDs, corticosteroids
- •Contraindications to any of the medications in the study
- •Significant psychiatric disorders (Axis I disorder) (major depressive disorders, bipolar disorders, schizophrenia, etc.)
- •Hepatic (ALT and / or AST> 2 normal wave) or renal (serum creatinine> 2 mg / dl)
- •Convulsive conditions that require medication in the last 2 years
- •Planned regional analgesia and / or anesthesia (spinal or epidural)
- •Corticosteroid-dependent asthma
- •Autoimmune disorders
- •Antiarrhythmic drugs (verapamil, propafenone, amiodarone) that may interfere with the antiarrhythmic action of lidocaine
研究组 & 干预措施
Sevoflurane
Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
干预措施: Blood extraction (Biological)
Sevoflurane
Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
干预措施: Sevoflurane (Drug)
Total intravenous anesthesia
Patients will receive a general anesthesia with Propofol as anesthetic agent
干预措施: Blood extraction (Biological)
Total intravenous anesthesia
Patients will receive a general anesthesia with Propofol as anesthetic agent
干预措施: Propofol (Drug)
Total intravenous anesthesia and Lidocaine
Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol
干预措施: Lidocaine 1% Injectable Solution (Drug)
Total intravenous anesthesia and Lidocaine
Patients will receive a general anesthesia with Propofol as anesthetic agent and will also receive a fully lidocaine infusion according to the lidocaine protocol
干预措施: Blood extraction (Biological)
结局指标
主要结局
Evaluation of the antiproliferative and apoptotic effects of anesthetic agents
时间窗: up to 4 years
The investigators aim to correlate the anticancer effects of two anesthetic techniques with tumor markers (p53;p38) and cell proteins involved in proliferation or apoptosis (IGFR;Bcl-2;Bcl-6). The investigators will report if the anesthetic agent used in cancer surgery influences the serologic values of these markers.
Evaluation of patients serum on cell culture
时间窗: up to 1 week
The investigators will investigate the serum of the patients who received different types of anesthesia (elective colorectal cancer surgery) by incubating it with colon cell lines (HCT116). The investigators will concentrate on cell proliferation assay. The investigators aim to discover how the growth of HCT116 will be influenced by patients' serum in terms of rate of proliferation. The measurements which will be used are Inhibitory Concentration (IC50) measured at 0 , 24 and 48 hours after incubation. The concentrations will be measured in mcg/ml.
次要结局
- Lidocaine concentration(up to 4 years)
- Survival Comparison(up to 5 years)
研究者
Alexandru Alexa
Principal Investigator
Iuliu Hatieganu University of Medicine and Pharmacy