Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Postoperative Visual Analogue Scale (VAS) score
研究概览
简要总结
The goal of this clinical trial is to compare Opioid Free and Opioid Based Anaesthesia in patients undergoing sleeve gastrectomy. The main questions it aims to answer are:
- Will the total dose of intraoperative opioid be reduced?
- Will there be difference in pain scores between groups? Participants will be managed with the Nociceptive Level Index algorithm to guide intraoperative analgesia.
The Opioid Free Anaesthesia Group will be administered the Multimix infusion (Magnesium sulfate, dexmedetomidine, ketamine). The Opioid Based Anaesthesia Group will receive fentanyl as a bolus dose and remifentanil infusion.
Rescue fentanyl bolused will be injected as appropriate according to nociceptive level (NOL) values.
详细描述
Opioid Free Anaesthesia has attracted the attention of clinicians since the outbreak of the opioid pandemic in the USA. It has been correlated with less intraoperative and postoperative opioid use. The Nociceptive Level Index algorithm allows for intraoperative monitoring of the nociceptive pathways and targeted pain management. Furthermore, it is known that morbidly obese patients may benefit from opioid sparing techniques.
Our aim is to investigate the effect of Opioid Free versus Opioid Based Anesthesia on postoperative pain in patients undergoing sleeve gastrectomy.
In this randomized, double blind clinical trial, patients will be allocated into two groups based on intraoperative pain management. Apart from recording postoperative pain scores, blood samples will be collected intraoperatively to evaluate the stress response among the two groups.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Infusions will be prepared by independent staff not involved in the study. All preparations will be alike in the volume and appearance.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18y and <75y
- •morbid obesity confirmed diagnosis
- •American Society of Anesthesiologists (ASA) II-III
- •elective laparoscopic sleeve gastrectomy surgery
- •signed informed consent
排除标准
- •bradycardia, bundle branch block, hypotension, postural hypotension
- •obstructive sleep apnoea
- •history of depression
- •chronic corticosteroid use or intraoperative administration of more than 8mg of prednisolone or equivalent
- •refusal to participate
研究组 & 干预措施
Opioid Based Anaesthesia
This arm will receive:
- 2 mcg/kg fentanyl in 10 ml volume
- 0.2 mL/kg/h remifentanil infusion
- 0.1 mg/kg morphine
干预措施: Opioid based anesthesia (Drug)
Opioid Free Anaesthesia
This arm will receive
- 40 mg/kg magnesium sulfate in 100 ml N/S infusion
- 0.4 mcg/kg dexmedetomidine, max total dose 50mcg in 50 ml N/S infusion
- 0.3 mg/kg ketamine in 10 ml volume
- 0.2 ml/kg of the Multimix regimen in 100 ml N/S infusion as a bolus (The Multimix regimen consists of 50mcg dexmedetomidine, 500 mg lidocaine and 50mg ketamine).
- 0.2 ml/kg/h of the Multimix regimen in 100 ml N/S infusion as a continuous infusion
干预措施: Opioid Free Anaesthesia (Drug)
结局指标
主要结局
Postoperative Visual Analogue Scale (VAS) score
时间窗: 6 hours after surgery
The patient will be interviewed regarding postoperative pain using Visual Analogue Scale, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable
次要结局
- First demand for supplementary analgesia(Up to 24 hours postoperatively)
- Postoperative VAS score(24 hours)
- Perioperative trend of Adrenaline(At baseline, at the end of the operation, 24 hours after surgery)
- Perioperative trend of Noradrenaline(At baseline, at the end of the operation, 24 hours after surgery)
- Perioperative trend of Cortisol(At baseline, at the end of the operation, 24 hours after surgery)
- Perioperative trend of Dopamine(At baseline, at the end of the operation, 24 hours after surgery)
研究者
Panagiotis Chatzistavridis
Principal Investigator
G.Gennimatas General Hospital