Quality of Recovery of Opioid Free Anaesthesia Versus Opioids Anaesthesia Within Enhanced Recovery Protocol Following Laparoscopic Sleeve Gastrectomy in Saudi Arabia, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Quality of recovery 40 questionnaire (QoR-40)
研究概览
简要总结
Laparoscopic sleeve gastrectomy is widely employed nowadays. Multimodal analgesia approach is implemented within the enhanced recovery protocol in our facility to improve participants' recovery. Due to side effects of narcotics, the may adversely affect the quality of recovery, the investigators intended to test the efficacy of opioids free anaesthesia on the quality of recovery and postoperative narcotic use.
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)
盲法说明
only the anaesthetist is one aware of the study groups
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •70 ASA II - III adult patients (18-60 years old)
- •Elective laparoscopic bariatric surgery.
- •Body mass index (BMI) is from 40 to 60
- •Trocar sites at or above the umbilicus (T 10 dermatome).
排除标准
- •Allergy to amino-amide local anaesthetics,
- •presence of coagulopathy
- •local skin infection at injection sites,
- •preoperative chronic dependence upon opioid and NSAID medications,
- •liver or renal insufficiency,
- •history of psychiatric or neurological disease, deafness,
- •previous open surgery,
- •patients who need to be converted to open surgery with more tissue trauma,
- •ASA (American society of anesthesiologists) class above III were excluded.
研究组 & 干预措施
Opioids anesthesia
received propofol-fentanyl induction of anaesthesia plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
干预措施: Fentanyl (Drug)
Opioids anesthesia
received propofol-fentanyl induction of anaesthesia plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
干预措施: Oblique subcostal transversus abdominis plane block (Procedure)
OFA
received preinduction with dexmeditomidine 0.1µg.kg-1 over 10 min. Induction with propofol 1.5 mg.kg-1-ketamine (ketofol 3:1 mixture) induction plus maintenance mixture of dexmedetomidine 0.5µg.kg-1.h-1, ketamine 0.5mg.kg-1.h-1, and lidocaine 1 mg.kg-1.h-1 plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
干预措施: Ketamine (Drug)
OFA
received preinduction with dexmeditomidine 0.1µg.kg-1 over 10 min. Induction with propofol 1.5 mg.kg-1-ketamine (ketofol 3:1 mixture) induction plus maintenance mixture of dexmedetomidine 0.5µg.kg-1.h-1, ketamine 0.5mg.kg-1.h-1, and lidocaine 1 mg.kg-1.h-1 plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
OFA
received preinduction with dexmeditomidine 0.1µg.kg-1 over 10 min. Induction with propofol 1.5 mg.kg-1-ketamine (ketofol 3:1 mixture) induction plus maintenance mixture of dexmedetomidine 0.5µg.kg-1.h-1, ketamine 0.5mg.kg-1.h-1, and lidocaine 1 mg.kg-1.h-1 plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
干预措施: Oblique subcostal transversus abdominis plane block (Procedure)
OFA
received preinduction with dexmeditomidine 0.1µg.kg-1 over 10 min. Induction with propofol 1.5 mg.kg-1-ketamine (ketofol 3:1 mixture) induction plus maintenance mixture of dexmedetomidine 0.5µg.kg-1.h-1, ketamine 0.5mg.kg-1.h-1, and lidocaine 1 mg.kg-1.h-1 plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side
干预措施: Lidocaine (Drug)
结局指标
主要结局
Quality of recovery 40 questionnaire (QoR-40)
时间窗: At 24th h (period of time between 6 and 24 hours) as repeated measurement
postoperative quality of recovery
次要结局
- Numerical rating scale (NRS)(24 hours)
- Pethidine consumption(24 hours)