NCT07073846 Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
| NCT ID | NCT07073846 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Instituto Mexicano del Seguro Social |
| Condition | Morbid Obesity Requiring Bariatric Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 104 participants in total. It began in 2025-10-06 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 renal impairment). * Severe hepatic impairment (Child-Pugh C). * Pregnancy or lactation. * Chronic opioid consumption \> 30 mg oral morphine equivalents per day for \> 4 weeks * Active seizure disorder, myasthenia gravis, or other neurologic disease contraindicating lidocaine infusion. * Patient cannot communicate * Patient does not want to fill in the questionnaire * Participation in another interventional study within the past 30 days. * Intra-operative conversion to open surgery. * Insufficient biological sample for biomarker analysis. * Premature discontinuation of the study drug during surgery for any reason that, in the judgement of the treating anaesthesiologist or investigators, prevents adequate exposure or assessment of safety variables (e.g., major haemorrhage \> 200 mL, anaphylactic shock, failed intubation, inability to extubate, severe metabolic/respiratory acidosis, transfer to ICU while intubated).
Contact & Investigator
Dulce María Rascón Martínez, Prof MD, MSc
PRINCIPAL INVESTIGATOR
Instituto Mexicano del Seguro Social
Frequently Asked Questions
Who can join the NCT07073846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Morbid Obesity Requiring Bariatric Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07073846 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07073846 currently recruiting?
Yes, NCT07073846 is actively recruiting participants. Contact the research team at dradulcerascon@gmail.com for enrollment information.
Where is the NCT07073846 trial being conducted?
This trial is being conducted at Mexico City, Mexico, Mexico City, Mexico.
Who is sponsoring the NCT07073846 clinical trial?
NCT07073846 is sponsored by Instituto Mexicano del Seguro Social. The principal investigator is Dulce María Rascón Martínez, Prof MD, MSc at Instituto Mexicano del Seguro Social. The trial plans to enroll 104 participants.
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