Tests lidocaine and dexmedetomidine for pain after weight-loss surgery
Tests a lidocaine and dexmedetomidine drug combination in adults with obesity after bariatric surgery.
Plain-language title generated from the registry record
Registry title: Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
Key facts
- Where
- Mexico City, MexicoSee the 2 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07073846, who can take part
Where in Mexico
- Hospital de Especialidades Centro Médico Nacional Siglo XXIMexico City, MexicoTaking people
- Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXIMexico City, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Instituto Mexicano del Seguro Social
- Trial code
- NCT07073846
- Record updated
- 28 November 2025
- Original description
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.Read full original descriptionShow less
Efficacy of Lidocaine-Dexmedetomidine Combination Therapy in Reducing Post-Operative Pain, Inflammatory Response, and Oxidative Stress in Patients Undergoing Bariatric Surgery
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.
Inclusion: 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: Current substance abuse or illicit drug use; Previous abdominal surgery within the last 6 months; Intra-operative conversion to open surgery; 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; Severe hepatic impairment (Child-Pugh C); Active seizure disorder, myasthenia gravis, or other neurologic disease contraindicating lidocaine infusion; 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); Estimated glomerular filtration rate (eGFR) < 60 mL min-¹ 1.73 m-² (moderate-to-severe renal impairment); 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); Pregnancy or lactation; Chronic opioid consumption > 30 mg oral morphine equivalents per day for > 4 weeks; Patient cannot communicate; Patient does not want to fill in the questionnaire; Participation in another interventional study within the past 30 days; Insufficient biological sample for biomarker analysis.