Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Quality of recovery using QoR-15
研究概览
简要总结
Opioids are widely used during anesthesia for pain control, but they cause many side effects-such as nausea, constipation, respiratory depression, dependence, and delayed recovery. They can also worsen low blood pressure in patients with unstable circulation. Because of these risks, multimodal analgesia is recommended to reduce opioid use.
Research on other non-opioid options is limited. Systemic lidocaine offers anti-inflammatory and opioid-sparing benefits and improves recovery in elective colorectal surgery, but its role in emergency laparotomy is still unclear and requires further study.
详细描述
Upon arrival to the operating room, routine monitors will be applied; intravenous line will be secured, and 8 mg dexamethasone will be slowly administrated. Baseline preoperative blood pressure will be recorded as the average of three readings with difference less than 5 mmHg.
Preoperative fluid management Fluid responsiveness will be defined as a 10% increase in stroke volume after passive leg raising maneuver. Fluid responder will be given 500-mL bolus of lactated ringer. Passive leg raising will be repeated until wither the patient is non-responder or 1500 mL were infused.
induction of anesthesia: 2 mg/kg propofol and 1 mg/kg succinyl choline. Anesthesia will be maintained by isoflurane in air/oxygen admixture (with target end tidal isoflurane 1-1.2%). Atracurium will be administered after patient recovery from succinylcholine at a dose of 0.5 mg/Kg and then regularly according to local protocols.
A 10-12 mL/kg/hr of lactated ringer will be infused during the procedure. Heart rate and blood pressure will be monitored at 2 min intervals. The average of every 5 successive readings would be recorded every 10 min. If patients developed hypotension (mean arterial pressure (MAP) ≤ 70% of the baseline reading and/or <65 mmHg), a fluid bolus of 4 mL/kg will be given and the change in the pulse pressure will be noted. If the pulse pressure increases by >10 %, the fluid bolus will be given until the increase in pulse pressure is <10%. If hypotension persists despite the adequate volume replacement a 5-mcg bolus of norepinephrine will be given. The bolus will be repeated if MAP was not restored within 2 min. Infusion of norepinephrine can be given if MAP persisted <65 mmHg despite 5 boluses of norepinephrine.
If bradycardia occurred (defined as heart rate less than 55 bpm), it will be managed by IV atropine bolus (0.5 mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (21-65 years), ASA I-III undergoing emergency laparotomy with midline incision
排除标准
- •Severe cardiac morbidities (impaired contractility with ejection fraction < 45%, heart block, arrhythmias, tight valvular lesions)
- •Patients on vasopressor infusion, patients with high shock index (heart rate / systolic blood pressure >1)
- •Body mass index <18 or > 35 Kg/m2,
- •Pregnant or lactating women,
- •Allergy of any of the study drugs
- •Severe liver cell failure and renal impairment by history and/or abnormal liver and kidney function tests.
研究组 & 干预措施
lidocaine group
lidocaine bolus at induction followed by infusion until the end of procedure
干预措施: Lidocaine (drug) (Drug)
Fentanyl group
fentanyl bolus at induction followed by saline infusion until the end of procedure
干预措施: Fentanyl (IV) (Drug)
结局指标
主要结局
Quality of recovery using QoR-15
时间窗: 24 hours after surgery
The QoR-15 scale is a global measure of postoperative recovery, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR)
次要结局
- mean arterial pressure(at baseline preoperatively, every 10 minutes (averaging of each 5 readings) from induction of anesthesia until end of procedure, and 2, 6, 10, 16, 24 hours postoperatively.)
- intraoperative fentanyl consumption(from time of induction of anesthesia until end of procedure)
- heart rate(at baseline preoperatively, every 10 minutes (averaging of each 5 readings) from induction of anesthesia until end of procedure, and 2, 6, 10, 16, 24 hours postoperatively.)
- Oxygen saturation/ fraction of inspired oxygen (SF ratio)(30 minutes postoperative)
- postoperative opioid consumption(from extubation until 24 hours postoperatively)
- numeric rating scale(30 minutes, 2-, 6-, 10-, 16-, 24 hours postoperatively)
- serum lactate(30 minutes postoperative)
- respiratory rate(30 minutes postoperative)