Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy (O-S Anesthesia)

Cairo University (CU)

Status: Not yet enrolling

Conditions: Anesthesia Recovery Period

Treatments: Drug: A 10-mL syringe of 10 mcg/mL fentanyl (induction syringe) and a 50-mL syringe of saline (infusion syringe) will be prepared as placebo.; Drug: : two syringes of lidocaine 10 mg/mL will be prepared. A 10-mL syringe (induction syringe) will be given during the induction of anesthesia and A 50 mL syringe (infusion syringe) will be used as conti

Study type: Interventional

Funder types: Other

Identifiers

NCT06889090

ty7890567

Details and patient eligibility

About

Aim of the Work The investigators aim to compare lidocaine-based anesthesia versus conventional anesthesia in the presence of multimodal analgesia protocol in terms of early quality of recovery and analgesic efficacy.

Objectives To compare quality of recovery using the Quality of recovery-15 (QoR-15) score between lidocaine-based anesthesia in relation to conventional anesthesia in patients undergoing emergency laparotomy.

Hypothesis the investigators hypothesize that lidocaine-based regimen would be effective in reducing opioid use and provide superior quality of recovery compared to conventional opioid-routine anesthesia in emergency laparotomy.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (18-65 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) and patients on beta-blockers

• 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,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

opioid sparing

Active Comparator group

Description:

two syringes of lidocaine 10 mg/mL will be prepared. A 10-mL syringe (induction syringe) will be given during the induction of anesthesia and A 50 mL syringe (infusion syringe) will be used as continuous infusion.

Treatment:

Drug: : two syringes of lidocaine 10 mg/mL will be prepared. A 10-mL syringe (induction syringe) will be given during the induction of anesthesia and A 50 mL syringe (infusion syringe) will be used as conti

conventional

Placebo Comparator group

Description:

A 10-mL syringe of 10 mcg/mL fentanyl (induction syringe) and a 50-mL syringe of saline (infusion syringe) will be prepared as placebo.

Treatment:

Drug: A 10-mL syringe of 10 mcg/mL fentanyl (induction syringe) and a 50-mL syringe of saline (infusion syringe) will be prepared as placebo.