Randomized, Double-blind, Placebo-controlled Single-centre Clinical Trial Evaluating Efficacy and Safety of Intraoperative and Postoperative Continuous Lidocaine Infusion in High Cardiac Risk Vascular Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Opioid consumption in the intraoperative period
研究概览
简要总结
The aim of the study is to test the effectiveness and safety of the use of lidocaine infusion in multimodal analgesic management. A group of patients undergoing vascular surgery performed with the classic technique on the aorta - with the opening of the abdominal cavity will be enrolled. The population of patients qualified for this type of vascular surgery is usually burdened with multiple diseases, mainly risk factors or cardiovascular diseases, which, combined with hemodynamic fluctuations, large fluid shifts (including bleeding) and stress for the body, affects the risk of serious cardiological complications, which in this group exceeds 5% and is the highest, according to the ESC / ESA (European Society of Cardiology / European Society of Anesthesiology) classification from 2014. Proper postoperative pain control is therefore becoming one of the key pillars of postoperative care in this group of patients.
Due to the numerous disease burden of patients and the operational specifics, the use of multimodal therapy in the management of pain is of particular importance, as the use of high doses of opioids improves hemodynamic stability, but at the same time affects the occurrence of side effects - mainly excessive sedation, respiratory disorders, hypoventilation and, consequently, for hypoxia of the heart muscle. The risk of myocardial injury in non-cardiac surgery (MINS) is significant in the light of the available literature.
Lidocaine used in intravenous infusion is one of the recommended components of multidirectional analgesia. Its adjuvant properties make it possible to reduce the amount of opioid drugs used, and thus - to reduce the frequency of their side effects. The high effectiveness of such a procedure has been proven in numerous experimental and epidemiological studies. Due to the low frequency of side effects associated with its use, the therapy has a strong recommendation for use in relieving perioperative pain. The analysis of the literature on the subject shows that there is little data assessing effectiveness of lidocaine infusion in relation to the group of patients after surgery on the abdominal aorta.
详细描述
All enrolled participants will be randomized, using random-number generator, to two groups - group A (intervention - perioperative continuous infusion of lidocaine) and group B (without intervention - perioperative continuous infusion of placebo). Study is designed as double-blinded: neither patients nor perioperative care givers (surgeons, anesthetists, nurses) will be aware to which group a patient has been assigned. A coordinator of randomization process will be responsible to ask an anesthetist or a nurse (a person not taking part in participant's perioperative care) to prepare a set containing respectively: 40 ml of 1% lidocaine or 40 ml of 0,9% NaCl (placebo) before surgery. Syringes will be labeled "Tested Drug". All data regarding patient's assignment to the respective groups will be available only to the coordinator of the study.
Anaesthesia will be performed by anesthetist experienced in vascular surgery. Every patient will be premedicated with midazolam (3,75mg-15 mg orally), adjusted to his/her body weight. Premedication efficacy will be assessed before induction using RASS scale (Richmond Agitation-Sedation Scale).
During induction of anaesthesia: fentanyl (0,01-0,02 mg / kg i.v.), propofol (1-2 mg/kg i.v.), atrakurium (0,5 mg/kg i.v.) will be given. Depth of anaesthesia will be monitored with BIS index (bi-spectral index) or entropy till the emergence. Patients scoring above 2 points in APFEL scale will receive antiemetic drug - ondansetron 8 mg i.v..
Intraoperative monitoring will consist of: non-invasive (NIBP) or invasive blood pressure monitoring (IBP), anesthetic agent concentration monitoring (MAC, minimal alveolar concentration), pulse oximetry (SpO2), capnometry (etCO2) and anesthetic depth monitoring as above.
During co-induction mechanical ventilation will be performed in CMV mode (controlled mechanical ventilation). Breathing frequency will be adjusted to etCO2 values. Tidal volume will be set on 6-8 ml/ kg IBW (ideal body weight) and positive end-expiratory pressure set on 5 cm H2O. Fresh gases flow mixture will be adjusted according to SpO2 92-100% values. After induction, desflurane will be used in concentrations maintaining depth of anaesthesia between 40-60 BIS/entropy values. In case of BIS/entropy values out of the range during anesthesia, all the events and duration time will be recorded. After general anesthesia mean anesthetic concentration will be counted and recorded.
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)
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
- •Written informed consent
- •Vascular surgery on aorta or iliac artery
- •Proximal anasthomosis of a by-pass in the abdominal cavity
排除标准
- •Contraindications for administration of lidocaine (according to Summary Product Characteristics)
- •Preoperative administration of any pain relief medication in patient, especially opioides (excluding pre-analgesia)
- •Heart block second or third-degree, previous pacemaker implantation, chronic atrial fibrillation
- •Antiarrhythmic medication on regular basis (excluding b-blockers prescribed due to coronary artery disease)
- •Other health problems: chronic heart failure (ejection fraction LVEF<30%), epilepsy or any episode of seizure, chronic renal failure (AKIN 3-5), chronic liver failure ( class B or C in the Child-Pugh classification), Myasthenia gravis, hypoproteinemia,
- •Cognitive or mental dysfunction, that prevents proper cooperation.
研究组 & 干预措施
Lidocaine infusion
Before induction bolus of 1% lidocaine 1,5mg/kg IBW i.v., continuous infusion of 1% lidocaine intraoperatively rate 2 mg/kg IBW i.v., continuous infusion of 1% lidocaine postoperatively rate 1 mg/kg IBW i.v. for 24 hours
干预措施: lidocaine 10mg/ml (Drug)
Lidocaine infusion
Before induction bolus of 1% lidocaine 1,5mg/kg IBW i.v., continuous infusion of 1% lidocaine intraoperatively rate 2 mg/kg IBW i.v., continuous infusion of 1% lidocaine postoperatively rate 1 mg/kg IBW i.v. for 24 hours
干预措施: Metamizole (Drug)
Lidocaine infusion
Before induction bolus of 1% lidocaine 1,5mg/kg IBW i.v., continuous infusion of 1% lidocaine intraoperatively rate 2 mg/kg IBW i.v., continuous infusion of 1% lidocaine postoperatively rate 1 mg/kg IBW i.v. for 24 hours
干预措施: Morphine (Drug)
Saline infusion
equal volumes of placebo - 0,9% saline i.v.
干预措施: Placebo (Drug)
Saline infusion
equal volumes of placebo - 0,9% saline i.v.
干预措施: Metamizole (Drug)
Saline infusion
equal volumes of placebo - 0,9% saline i.v.
干预措施: Morphine (Drug)
结局指标
主要结局
Opioid consumption in the intraoperative period
时间窗: Duration of general anaesthesia
Dose of morphine (or fentanyl changed to the equivalent dose of morphine) administered to patient to achive pain score below 4 points (VAS scale)
Opioid consumption in the postoperative period
时间窗: First 24 hours after surgery
Dose of morphine administered to patient to achive pain score below 4 points (VAS scale)
Consumption of the anesthetic agent
时间窗: Duration of general anesthesia
The Mean/median vaule of minimal alveolar concentration (MAC) necessary to maintain general anesthesia
Hemodynamic stability
时间窗: Duration of general anesthesia
Comparison of systolic and mean blood pressure value to value (5 minutes interval, comparison of exceeding 10% of the previous value, total number of exceedances)
Number of hemodynamic intervations
时间窗: Duration of general anesthesia
Total number hemodynamic interventions (total dose of vasoactive medication use according to study protocol)
Intraoperative fulid therapy
时间窗: Duration of general anesthesia
Total amount and type of fluids, blood products administered to patient
次要结局
- The Incidence of postoperative delirium(First 72 hours (after surgery), once per shift)
- Indicators of safety(Intraoperatively and first 24 hours (after surgery))
研究者
Łukasz Krzych
Professor
Medical University of Silesia