Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia: a Randomised Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean of the nociception level as measured by the PMD-200
研究概览
简要总结
The aim of this double blind, randomised controlled non-inferiority trial is to compare the antinociceptive efficiency of an opioid-sparing and a conventional opioid-based anaesthesia protocol with the help of the CEcertificated Pain Monitoring Device (PMD-200).
详细描述
Opioids have been an integral part of general anaesthesia. They are effective in preventing perception of noxious stimuli and ensure intraoperative haemodynamic stability. However, opioids are associated with a number of unwanted side effects (e.g. nausea and vomiting, sedation, ileus, respiratory depression, increased postoperative pain and morphine consumption and hyperalgesia). To minimise these side effects, there has been an interest in developing opioid-sparing anaesthesia protocols. Recently, analgesia nociception monitoring devices have become available. The aim of this double blind, randomised controlled non-inferiority trial is to compare the antinociceptive efficiency of an opioid-sparing and a conventional opioid-based anaesthesia protocol with the help of the CEcertificated Pain Monitoring Device (PMD-200). Patients scheduled to receive general surgical, gynaecological or urological laparoscopic surgery will be randomised into one of the two study groups. Study group A will be anaesthetised with an opioid-sparing protocol and study group B will be anaesthetised with a conventional opioid-based protocol. Intraoperative nociception will be evaluated with PMD-200. Postoperative visits will take place in recovery, 4-5h after surgery and then twice a day. In recovery, the amount of opioids and ketamine needed, pain, postoperative nausea and vomiting (PONV) and the time until the patient is fit for discharge according to the Aldrete score will be assessed. At the 4-5h postoperative visit, the amount of opioids and ketamine needed, maximum pain at rest and at mobilisation, incidence of PONV, mobilisation, micturition and sedation level will be assessed. At the twice daily follow up visits, amount of opioids and other analgesic drugs needed, pain at rest and at mobilisation, gastrointestinal function, quality of night's sleep, incidence of PONV, level of sedation and fitness for discharge home will be assessed. On day one after surgery, the perceived quality of recovery will be assessed with the QoR40 questionnaire.
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
- Double (Participant, Investigator)
盲法说明
The patient and the investigator carrying out the nociception level measurement and the postoperative assessments will be blinded to the type of anaesthesia protocol that the patient is allocated to.
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
- •Informed Consent as documented by signature
- •Age older than 18 years
- •Ability to give informed consent
- •Undergoing scheduled general surgical, gynaecological or urological laparoscopic surgery
- •American Society of Anesthesiology Score (ASA) status I, II, III
排除标准
- •Inability to give informed consent
- •ASA status IV and V
- •Pregnant or breastfeeding women
- •Allergy to one of the study drugs
- •Urgent surgery
- •Surgery with planned regional anaesthesia
- •Outpatient surgery
- •Atrioventricular block, intraventricular or sinoatrial block
- •Atrial fibrillation
- •Sinus bradycardia
- •Cardiac insufficiency with a reduced left ventricular ejection fraction of below 40%
- •Coronary artery disease
- •Liver cirrhosis
- •Chronic kidney disease (Clearance < 50ml/h)
- •Chronic opioid therapy
- •Chronic pain
研究组 & 干预措施
Opioid-sparing: Lidocaine, Ketamine, Magnesium, Clonidine, Fentanyl, Remifentanil, Propofol
Ketamine: started at 5mg/h; continued until 30min before end of surgery, then reduced to 1mg/h until discharge from recovery.
Fentanyl: bolus of 50mcg before skin incision (in case of insufficient analgesia further boluses of 25mcg, upper limit is 100mcg).
Lidocaine: bolus of 1.5mg/kg of ideal body weight (IBW),(maximum 100mg) at induction of anaesthesia, then continuous infusion of 1.5mg/kg IBW/h (maximum 100mg/h) until discharge from recovery.
Magnesium: infusion of 2g/h for a maximum of 2h after induction of anaesthesia (maximum dose 4g). In case of bradycardia or hypotension, rate is reduced to 1g/h.
Clonidine: bolus of 15mcg if needed. Maximum amount 150mcg. Remifentanil: started at time of induction of anaesthesia until end of surgery.
干预措施: opioid-sparing group (Drug)
Conventional group: Fentanyl, Remifentanil, Propofol
Control Intervention:
Remifentanil: Remifentanil is given as a target controlled infusion using the Minto-model. It is started at the timepoint of induction of anaesthesia and given until the end of surgery.
Fentanyl: 2mcg/kg i.v. is given at the time of induction of anaesthesia and another 1-2mcg/kg is given prior to incision. Further fentanyl boluses (1-2mcg/kg boluses) are given in case there seems to be insufficient analgesia.
干预措施: conventional opioid-based group (Drug)
结局指标
主要结局
Mean of the nociception level as measured by the PMD-200
时间窗: From the timepoint of skin incision until skin closure (within 1 day)
The PMD-200 device consists of a finger probe which continuously assesses pulse rate, pulse rate variability, pulse wave amplitude, skin conductance level, skin conductance fluctuations, skin temperature, and finger motion. A value of 0 corresponds to no pain and a value of 100 to maximal pain. A value will be measured every minute from the timepoint of skin incision until skin closure.
次要结局
- Change in Aldrete score(Every 15 minutes in recovery until patient discharge to the ward (within 1 day))
- Perceived quality of recovery by QoR40 questionnaire(At the first postoperative day)
- Quality of night's sleep(From the first postoperative day until discharge from ward (average of 1 week))
- Occurrence of nausea and vomiting(From the stay in recovery before discharge from the ward (average of 1 week))
- Change in level of sedation(At 4 hours and then twice daily until discharge from the ward (average of 1 week))
- Change in pain score at rest by numeric rating scale(From the stay in recovery before discharge from the ward (average of 1 week))
- Amount of morphine needed(From the stay in recovery before discharge from the ward (average of 1 week))
- Amount of ketamine needed(From the stay in recovery before discharge from the ward (average of 1 week))
- Change in pain score at movement by numeric rating scale(From the stay in recovery before discharge from the ward (average of 1 week))
- Time to return of gastrointestinal function(From the stay in recovery before discharge from the ward (average of 1 week))
- Time to return of spontaneous micturition(From the stay in recovery before discharge from the ward (average of 1 week))