NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dosage of NKs activity after surgery
研究概览
简要总结
Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread.
A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of the innate immune system. Several factors of the perioperative period can reduce activity of NKs such as stress, pain, opioids and general anaesthetics.
Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption, ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic inflammation as well.
The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries for colorectal cancer resection will preserve NKs activity.
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
- Double (Participant, Care Provider)
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
- •Patients admitted for resection of colorectal cancer under laparoscopic surgery
- •American Society of Anesthesiologists class I-III.
- •The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent.
排除标准
- •Subjects allergic to any of the study drugs.
- •BMI > 35 kg/m
- •Severe renal or hepatic failure.
- •Pregnancy.
- •Emergent procedure.
- •Heart failure NYHA > III.
- •Systolic blood pressure < 90 mmHg.
- •Advanced heart block (unless patient has a pacemaker).
- •Unstable angina and/or myocardial infarction within past 6 weeks.
- •FEV1 ≤ 0.8 L.
- •Oxygen-dependent patient.
- •Electrocardiographic abnormalities
- •Treatment with immunosupressive drugs, corticosteroids, NSAIDS, antiarythmic
- •Morphine intolerance or allergy
研究组 & 干预措施
Intravenous Lidocaine
Patients undergoing laparoscopic surgery for resection of colorectal cancer will benefit of an infusion of intravenous lidocaine from the induction of anesthesia untill one hour after PACU admission
干预措施: Intravenous Lidocaine (Drug)
Placebo
Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission
干预措施: Normal saline infusion (Drug)
结局指标
主要结局
Dosage of NKs activity after surgery
时间窗: compare the activity of NK cells on day 1 and day 3 after surgery
Dosage of NKs activity after surgery
次要结局
- Pain scores(pain scores from the PACU to the 3rd day after surgery)
- Morphine consumption(From the PACU to the 3rd day after surgery)
- Ileus time(Day 1 and Day 3 after surgery)
- Surgical complications(Within 3 days after surgery)
- Fentanyl dose(Operative time)
- Nausea and vomiting(From the PACU to the 3rd day after surgery)
- Major adverses events(Start of the surgery untill one hour after PACU ad;ission)
研究者
Louis-Philippe Fortier
Principal investigator
Maisonneuve-Rosemont Hospital