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Recruiting Phase 4 NCT07073846

Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.

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Trial Parameters

Condition Morbid Obesity Requiring Bariatric Surgery
Sponsor Instituto Mexicano del Seguro Social
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 104
Sex ALL
Min Age 18 Years
Max Age 60 Years
Start Date 2025-10-06
Completion 2027-05-01
Interventions
Intravenous Lidocaine infusion + Standard AnesthesiaIntravenous Dexmedetomidine infusion + Standard AnesthesiaLidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia

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Brief Summary

The goal of this randomized clinical trial is to find out whether giving an intravenous lidocaine + dexmedetomidine combination (LIDEX) during laparoscopic bariatric surgery can lower post-operative pain, inflammation, and oxidative stress in adults with obesity. The main questions it aims to answer are: * Pain control: Does LIDEX reduce pain 24 hours after surgery, as measured with the International Pain Outcomes Questionnaire (IPOQ)? * Biomarkers: Does LIDEX lower blood levels of key inflammatory cytokines-interleukin-1 beta (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interleukin-10 (IL-10)-and oxidative-stress markers-malondialdehyde (MDA), the reduced/oxidized glutathione ratio (GSH/GSSG), superoxide dismutase (SOD), and catalase-compared with the individual drugs or saline placebo? Researchers will compare four groups: lidocaine alone, dexmedetomidine alone, LIDEX, and placebo (saline solution, a look-alike substance that contains no drug) to learn which approach works best. Participants will: * Receive an intravenous infusion of their assigned study drug(s) during surgery. * Provide three small blood samples (before surgery, immediately after, and three hours after). * Complete a short pain questionnaire (IPOQ) 24 hours after surgery.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 - 60 years * Male or female * Elective laparoscopic bariatric surgery * Post-operative pathway: post-anaesthesia care unit (PACU) followed by standard ward, with an expected in-hospital stay ≥ 24 h * ASA physical-status II or III Exclusion Criteria: * Use of any loco-regional anaesthetic technique during the peri-operative period (transversus abdominis plane, paravertebral, spinal, epidural, erector spinae, or other abdominal wall blocks). * Current substance abuse or illicit drug use. * Previous abdominal surgery within the last 6 months. * Known hypersensitivity or allergy to lidocaine, dexmedetomidine, amide local anaesthetics, or α₂-adrenergic agonists. * Congestive heart failure, significant bradyarrhythmia, second- or third-degree atrio-ventricular block without pacemaker, severe hypotension, or current therapy with Class I/III anti-arrhythmic drugs. * Estimated glomerular filtration rate (eGFR) \< 60 mL min-¹ 1.73 m-² (moderate-to-severe rena

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