Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy: Clinical, Randomised Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Postoperative pain score in NRS scale
研究概览
简要总结
Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.
详细描述
The study has been approved by Bioethical Committee of Medical University of Warsaw. Informed written consent will be obtained from all patients. Sample size of 60 patients has been calculated based on the Altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%.
Consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia.
Opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil TCI Minto Model.
After the end of operation all of the patient will receive oxycodone and additional doses via PCA system for postoperative analgesia.
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, 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
- •Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
- •Written informed consent
排除标准
- •Patient's refusal
- •Known allergies to study medication
- •Inability to comprehend or participate In pain scoring scale
- •Inability to use intravenous patient controlled analgesia
- •Changes of operation extent during procedure
- •Revisional operations
研究组 & 干预措施
Opioid free group
干预措施: Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma] (Drug)
Opioid liberal group
干预措施: Remifentanil [Ultiva] (Drug)
Opioid free group
干预措施: Dexmedetomidine Hydrochloride [Dexdor] (Drug)
Opioid free group
干预措施: Ketamine [Ketalar] (Drug)
Opioid free group
干预措施: Lidocaine [Xylocaine 2%] (Drug)
Opioid free group
干预措施: Fentanyl [Fentanyl WZF] (Drug)
结局指标
主要结局
Postoperative pain score in NRS scale
时间窗: Day "1" assessed 24 hours after operation
NRS range from 0 for no pain to 10 for worst pain imaginable
Total postoperative oxycodone consumption
时间窗: Day "0"
PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes
次要结局
- Total ephedrine dosis(intraoperative)
- Postoperative desaturation(Day "0", assessed 1,6,12 and 24 hours after operation)
- Patient's comfort assessed in QoR-40 formulary(7 days postoperatively)
- Postoperative nausea and vomiting(Day "0", assessed 1,6,12 and 24 hours after operation)
- Rescue fentanyl administration dosis(intraoperative)
- Highest BP(intraoperative)
- Lowest BP(intraoperative)
- Highest HR(intraoperative)
- Lowest HR(intraoperative)
- Postoperative sedation score(Day "0", assessed 1,6,12 and 24 hours after operation)