Lidocaine plus dexmedetomidine during laparoscopic bariatric surgery to reduce pain, inflammation, and oxidative stress
Efficacy of Lidocaine-Dexmedetomidine Combination Therapy in Reducing Post-Operative Pain, Inflammatory Response, and Oxidative Stress in Patients Undergoing Bariatric Surgery
This trial will try giving an intravenous combination of lidocaine and dexmedetomidine during laparoscopic bariatric surgery in adults with obesity to see if it lowers pain, inflammation, and oxidative stress after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Instituto Mexicano del Seguro Social Government |
| Locations | 2 sites (Mexico City, Mexico City and 1 other locations) |
| Trial ID | NCT07073846 on ClinicalTrials.gov |
What this trial studies
This randomized Phase 4 trial compares four intraoperative infusions—lidocaine alone, dexmedetomidine alone, the combination (LIDEX), and saline placebo—each given with standard anesthesia during elective laparoscopic bariatric procedures. Patient-reported pain is measured 24 hours after surgery using the International Pain Outcomes Questionnaire, and perioperative blood samples are collected to measure inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-10) and oxidative-stress markers (MDA, GSH/GSSG, SOD, catalase). Hemodynamic parameters are continuously monitored intraoperatively to detect potential lidocaine toxicity or dexmedetomidine-related cardiovascular effects. Outcomes compare the combination to each single agent and to placebo in adults undergoing sleeve gastrectomy or gastric bypass.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–60 with morbid obesity scheduled for elective laparoscopic sleeve gastrectomy or gastric bypass who are ASA physical status II–III and can remain in hospital for at least 24 hours.
Not a fit: Patients with significant cardiac conduction disease, moderate-to-severe renal impairment, active substance abuse, recent abdominal surgery, those receiving perioperative regional anesthesia, or those outside the 18–60 age range are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could reduce postoperative pain and inflammation and help patients recover more quickly after bariatric surgery.
How similar studies have performed: Prior preclinical and clinical work shows that intravenous lidocaine or dexmedetomidine can reduce pain and inflammatory responses, and some smaller combination studies suggest additive benefits though data specific to bariatric surgery remain limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Mexico City, Mexico City and 1 other locations
- Hospital de Especialidades Centro Medico Nacional Siglo XXI — Mexico City, Mexico City, Mexico (Recruiting)
- Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI — Mexico City, Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Dulce María Rascón Martínez, Prof MD, MSc — Instituto Mexicano del Seguro Social
- Study coordinator: Dulce M Rascón Martínez, Prof MD, MSc
- Email: dradulcerascon@gmail.com
- Phone: + 52 55 5627 6900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.