Impact of Intraoperative Intravenous Lidocaine Administered During Laparoscopic Colorectal Surgery on Remifentanil Consumption, Postoperative Pain and Immune Cell Activity: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine ("IVL") group compared with the control group ("C"). Total consumption of remifentanil in mcg.
研究概览
简要总结
This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous lidocaine.
详细描述
Hypothesis: We hypothesize that the intravenous lidocaine (IVL) versus placebo administered during laparoscopic colorectal surgery will allow for: a reduction in intraoperative remifentanil consumption, an improvement in patients' early rehabilitation after surgery, and an enhancement of the immune profile of our patients through an increase in the balance Th1/Th2 and cellular immunity.
Background: so far, IVL was shown to have several properties: analgesic, anti-inflammatory, and anti-hyperalgesic. Its effects on rehabilitation and pain are still controversial except for abdominal surgery. To date, no study evaluated the impact of IVL in colorectal surgery on intraoperative consumption of remifentanil. Postoperative immune suppression is multifactorial and depends on the surgical traumatism, but also on the doses of opioids given during anesthesia. No study evaluated in colorectal surgery the impact of IVL on postoperative cellular immunity and on the risk of cancer recurrence.
Specific Objectives: primary objective: to reduce by 30% the consumption of remifentanil in the IVL group versus the placebo group; secondary objectives: to evaluate the quality of recovery from anesthesia in the OR (awakening and extubation time), in the PACU and on the wards (pain scores, opioid consumption with patient controlled analgesia (PCA), postoperative nausea and vomiting (PONV), transit recovery time, time in PACU and time in hospital), and to evaluate the postoperative inflammatory parameters and adaptative immune functions (Th1/Th2) until postoperative 48h.
Methods: 60 adult patients ASA 1-3 scheduled for elective laparoscopic colorectal surgery will be included in this randomized controlled trial. Randomisation will be into group Control (C) and Lidocaine (IVL). Anesthesia and monitoring will be standardized and accompanied with the monitoring of the depth of anesthesia (BISpectral index, Medtronic) and the depth of analgesia (NoL index, Medasense LTD, recorded on an observational manner). IVL group will blindly be administered intravenous 1.5 mg/kg lidocaine bolus and then 1.5 mg/kg/h until the end of the surgery as previously described. C group will receive the same amount (ml) of placebo. Statistics: a preliminary analysis (idem group C) showed that the total amount of remifentanil given for this type of surgery was 2481+/-985 mcg (duration 141+/-30Min). Considering that we wish to reduce by 30% the remifentanil consumption in the group IVL, the number of patients to be included per group is 30 (alpha 0.05 and beta 20%).
Significance/Importance: this study will evaluate the impact of IVL on intraoperative consumption of remifentanil but also on immune functions after surgery in order to reduce the risk of cancer recurrence. If this study brings positive results, this will lead to a significant change in clinical practice of anesthesia. This is a pilot study on the immune functions, but this might bring very strong results to ask for future grants on the impact of IVL on cancer recurrence.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The drug administered intraoperatively (intravenous lidocaine or intravenous placebo) will be blinded to patient, anesthesiologist, research nurse for the entire duration of the study.
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
- •ASA status I, II or III
- •Patients older than 18 years
- •Colonic surgery
- •Classical management of ERAS program patients in our center
排除标准
- •Arrhythmia, abnormal electrocardiographic , antiarrhythmic therapy
- •Immunosuppressive treatments, corticosteroids or long-term NSAIDs (multiple weekly doses) or during preoperative 48 hours
- •conversion intraoperative of a laparoscopic surgical technique to a laparotomy technique
- •Pregnant women
- •Inability to complete the questions related to this study
- •Inability to use hydromorphone postoperative PCA
- •Intolerance or allergy to lidocaine, hydromorphone or any other drug that is included in the protocol for perioperative management
- •Unexpected events leading to the exclusion:
- •Difficult unplanned intubation
- •Surgical complication requiring aggressive haemodynamic support (vasopressors, inotropes, transfusion)
研究组 & 干预措施
intravenous lidocaine (IVL)
Will receive during the colorectal surgery under General Anesthesia intravenous lidocaine bolus 1.5mg/kg at the beginning of anesthesia (induction) and 1.5mg/kg/h until the end of anesthesia.
干预措施: intravenous lidocaine (IVL) (Drug)
Placebo
Will receive the same volume of normal saline for the entire duration of anesthesia.
干预措施: Placebo (Other)
结局指标
主要结局
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine ("IVL") group compared with the control group ("C"). Total consumption of remifentanil in mcg.
时间窗: Intra-operative, 5 hours
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine group compared with the control group.
次要结局
- Evaluation of the length of stay in the recovery room based on the Aldrete scores (Score from 0 to 9)(in recovery room, 3 hours)
- Evaluation of the satisfaction of the patient scale 0 to 100 (%)(48 hours postoperatively)
- Assessment of total hospital duration of stay in hours(7 days postoperatively)
- Assessment of rehabilitation scores and cognitive functions(2 days)
- Evaluation of the number of remifentanil boluses given intraoperatively (n)(T0 to end of surgery, 5 hours)
- Assessment of total consumption of inhaled anesthetic desflurane in ml(intra-operative)
- Evaluation of time for extubation(post-operative 1 hour)
- Evaluation of the hydromorphone dose in mg used in the post-operative care unit (PACU) titration(in recovery room, 3 hours)
- Evaluation of the nausea and vomiting scores, 0 to 3 scale(48 hours)
- Evaluation of the time in hours required for the emission of a first gas in hours(5 days postoperatively)
- Assessment of cytokines in plasma(48 hours)
- total hydromorphone consumption (mg) after PACU, on wards(48 hours)
研究者
Philippe Richebe
Director of Research in Anesthesiology, MD, PhD
Ciusss de L'Est de l'Île de Montréal