Effect of Opioid-sparing Anesthesia on Quality of Recovery After Emergency Laparotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine (drug), Fentanyl (IV).
- Who it may be relevant to
- Registry conditions: Emergency Abdominal Surgery, Opioid Sparing Anaesthesia. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy: a Randomized Controlled Trial
Overview
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.
Detailed description
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).
Intraoperative tachycardia and/or hypertension (defined as 20% increase from the baseline value) will be managed by fentanyl bolus of 0.5 mcg/kg, in absence of other causes.
At the end of the procedure, all patients will receive 1 gm of paracetamol intravenously and local infiltration of the wound with 40 mL of 0.125% bupivacaine. Patients who are not indicated for extubation at the end of the surgery will be excluded from the study.
Postoperative management All patients will receive 1 gm/ 6h of paracetamol. Static (at rest) and dynamic (during cough) numerical rating scale (NRS) will be assessed at 0.5, 2, 6, 10, 16, 24 hr postoperatively. If the NRS\>3, a 2 mg morphine bolus will be given to be repeated after 30 min if pain persists.
4 mg of ondansetron will be given if patients developed nausea or vomiting.
Interventions
- Drug Lidocaine (drug)
induction bolus of 0.15 mL/kg of 10mg/ml lidocaine, followed by 0.15 mL/kg/h infusion (10 mg/mL lidocaine) until end of procedure - Drug Fentanyl (IV)
induction bolus of 0.15 mL/kg of 10mg/ml fentanyl, followed by 0.15 mL/kg/h infusion (saline) until end of procedure
Primary outcome measures
- Quality of recovery using QoR-15 [Time frame: 24 hours after surgery]
Secondary outcome measures (8)
- intraoperative fentanyl consumption [Time frame: from time of induction of anesthesia until end of procedure]
- mean arterial pressure [Time frame: 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.]
- heart rate [Time frame: 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.]
- postoperative opioid consumption [Time frame: from extubation until 24 hours postoperatively]
- numeric rating scale [Time frame: 30 minutes, 2-, 6-, 10-, 16-, 24 hours postoperatively]
- serum lactate [Time frame: 30 minutes postoperative]
- respiratory rate [Time frame: 30 minutes postoperative]
- Oxygen saturation/ fraction of inspired oxygen (SF ratio) [Time frame: 30 minutes postoperative]
Eligibility criteria
Inclusion criteria
- Adult patients (21-65 years), ASA I-III undergoing emergency laparotomy with midline incision
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Kasr Alainy Hospital — Cairo
Identifiers
NCT: NCT07262242 · MD-5-2025