Comparative Study Between the Performance of Opioid Free Anesthesia Versus Conventional Opioid Based Anesthesia Regarding Achievement of Enhanced Recovery in Laparoscopic Bariatric Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Time between the end of analgesic used and an Aldrete score > 9 (when applicable).
研究概览
简要总结
This Study aims to evaluate the efficacy of opioid free general anesthesia in achieving enhanced recovery after surgery (ERAS) in laparoscopic bariatric surgery in terms of post-operative recovery time, cumulative pethidine consumption and number of episodes of postoperative nausea and vomiting(PONV).
详细描述
While opioids have been commonly used in the operating room due to their effectiveness in pain management and anesthesia, there are numerous common side effects that have an impact on patient recovery. Obese patients or those with pre-existing respiratory difficulties such as sleep apnea or chronic obstructive pulmonary disease are more likely to experience respiratory failure after getting opiate therapy. Other effects of opioid use include gastro-intestinal obstacles such nausea, vomiting, and constipation.
The concept of opioid-free anesthesia evolved due to the potential adverse side effects associated with intraoperative opioid usage.
This study examines nociceptive monitoring's potential role in opioid-free anesthesia, as well as research on the topic. This study aims to compare the effects of an opioid-free anesthesia (OFA) regimen versus an opioid-based anesthesia (OBA) regimen on postoperative pain and enhanced recovery in patients undergoing bariatric surgery.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing a scheduled laparoscopic bariatric surgery under general anesthesia.
- •Age group: 18-65 years old.
- •BMI greater than 35 to 50 Kg/m2
- •ASA physical status classes I and II.
排除标准
- •Patient refusal.
- •ASA physical status classes III and IV.
- •Anticipated difficult intubation.
- •Hypersensitivity to any drugs used in this study. Inability to extubate the patient at the end of the operation. Conversion to laparotomy. Patients for whom the anesthetic regimen is changed intraoperatively (from OFA to OBA or vice versa).
研究组 & 干预措施
Fentanyl infusion
Analgesia will be offered by fentanyl in induction and maintenance according to ideal body weight (IBW).
干预措施: Fentanyl infusion (Drug)
Dexamedomedine and ketamine infusion
Opioid free anesthesia Analgesia will be offered by syringe containing ketamine and dexmedetomidine in induction and maintenance according to IBW.
干预措施: Dexamedomedine and ketamine infusion (Drug)
结局指标
主要结局
Time between the end of analgesic used and an Aldrete score > 9 (when applicable).
时间窗: 15 minutes
Decrease opioid usage ,decrease recovery time
Time between the end of operation to PACU
时间窗: 15 minutes
Decrease opioid usage ,decrease recovery time
次要结局
- Cumulative pethidine consumption(24 hours postoperative)
- Number of episodes of nausea and vomiting [Time Frame: During the 24 hours following extubation].(24 hours postoperative)
研究者
Eman Mohamed Zain Eldeen
Doctor
Ain Shams University