Emergency Abdominal Surgery, Opioid Sparing Anaesthesia
Conditions
Brief summary
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
preoperatively, 8 mg dexamethasone will be slowly administrated. Fluid responsiveness will be defined as a 10% increase in stroke volume after passive leg raising maneuver. If responder will be given 500-mL bolus of lactated ringer. induction of anesthesia: 2 mg/kg propofol and 1 mg/kg succinyl choline. Anesthesia will be maintained by isoflurane in air/oxygen admixture. Atracurium will be administered after patient recovery from succinylcholine at a dose of 0.5 mg/Kg. A 10-12 mL/kg/hr of lactated ringer will be infused during the procedure. 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 5-10 mg bolus of ephedrine 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. 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. Postoperative management All patients will receive 1 gm/ 6h of paracetamol.
Interventions
DRUGLidocaine (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
DRUGFentanyl (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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery using QoR-15 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative fentanyl consumption | from time of induction of anesthesia until end of procedure | mcg/kg |
| 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. | mmHg |
| 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. | bpm |
| postoperative opioid consumption | from extubation until 24 hours postoperatively | nalbuphine in mg |
| numeric rating scale | 30 minutes, 2-, 6-, 10-, 16-, 24 hours postoperatively | rate pain on a scale of 0-10, 0: no pain, 10: worst pain |
| serum lactate | 30 minutes postoperative | — |
| respiratory rate | 30 minutes postoperative | — |
| Oxygen saturation/ fraction of inspired oxygen (SF ratio) | 30 minutes postoperative | — |
Countries
Egypt
Contacts
CONTACTMaha Mostafa, MD
Outcome results
None listed