RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

DRUG

Intravenous Lidocaine infusion + Standard Anesthesia

Continuous IV infusion of lidocaine 1 % (10 mg mL-¹) at 0.3 mL kg-¹ h-¹ (≈ 1.5 mg kg-¹ h-¹) from induction of anaesthesia to skin closure. No loading bolus, no post-operative infusion.

DRUG

Intravenous Dexmedetomidine infusion + Standard Anesthesia

Continuous IV infusion of dexmedetomidine 1 µg mL-¹ at 0.3 mL kg-¹ h-¹ (≈ 0.3 µg kg-¹ h-¹) without loading dose, started after induction and stopped at skin closure. No post-operative infusion.

DRUG

Lidocaine + Dexmedetomidine Combination (LIDEX) + Standard Anesthesia

Single syringe containing lidocaine 1 % (10 mg mL-¹) + dexmedetomidine 1 µg mL-¹, infused IV at 0.3 mL kg-¹ h-¹ (delivering ≈ 1.5 mg kg-¹ h-¹ lidocaine + 0.3 µg kg-¹ h-¹ dexmedetomidine) from induction to skin closure.

DRUG

0.9 % Saline Placebo + Standard Anesthesia

Volume-matched IV infusion of 0.9 % normal saline at 0.3 mL kg-¹ h-¹ for the same duration and through the same delivery line as active arms; identical syringe appearance.

Locations (2)

Hospital de Especialidades Centro Medico Nacional Siglo XXI

Mexico City, Mexico City, Mexico

Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI

Mexico City, Mexico City, Mexico