Clinical Trial

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

Recruiting Phase 4
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-16.
Status change: Not Yet Recruiting → Recruiting 2025-11-26
Trial Details
NCT Number NCT07073846
Lead Sponsor Instituto Mexicano del Seguro Social
Conditions Morbid Obesity Requiring Bariatric Surgery, Postoperative Pain, Postoperative Pain Management, Postoperative Analgesia, Postoperative Adjuvant Treatment, Postoperative Inflammatory Markers, Postoperative Inflammatory Response
Enrollment 104 participants
Start Date 2025-10-06
Primary Completion 2027-05-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-28