NCT07073846RecruitingPhase 4

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

Efficacy of Lidocaine-Dexmedetomidine Combination Therapy in Reducing Post-Operative Pain, Inflammatory Response, and Oxidative Stress in Patients Undergoing Bariatric Surgery

Source: ClinicalTrials.gov · Last updated 28 Nov 2025

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 104 (estimated)
First submitted: 30 Jun 2025
Start date: 6 Oct 2025
Primary completion date: 1 May 2027
Lead sponsor: Instituto Mexicano del Seguro Social
Diseases: Obesity
NCT number: NCT07073846

What you commit to

Study type: Interventional · Phase 4
Planned participants: 104
From 6 Oct 2025 to the primary completion date, 1 May 2027
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Current substance abuse or illicit drug use.
Previous abdominal surgery within the last 6 months.
Intra-operative conversion to open surgery.

Other illness

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).

Lab values

Estimated glomerular filtration rate (eGFR) \< 60 mL min-¹ 1.73 m-² (moderate-to-severe renal impairment).

Other

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.

Who the study is looking for

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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Hospital de Especialidades Centro Médico Nacional Siglo XXI Coordinator of this site? Confirm its status	Mexico City	Mexico	Recruiting
Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI Coordinator of this site? Confirm its status	Mexico City	Mexico	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.