Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
NCT ID: NCT07073846
Last Updated: 2025-11-28
Study Results
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Basic Information
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RECRUITING
PHASE4
104 participants
INTERVENTIONAL
2025-10-06
2027-07-01
Brief Summary
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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.
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Detailed Description
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Intravenous lidocaine stabilises voltage-gated Na+ channels, limits ectopic neuronal firing and inhibits neutrophil priming; it also down-regulates the release of pro-inflammatory cytokines in abdominal procedures. Dexmedetomidine, a highly selective α2-adrenergic agonist, produces sedation and analgesia while attenuating sympathetic outflow, thereby reducing surgical catecholamine surges and cytokine release. Pre-clinical and clinical synergy studies indicate that combining these two agents (LIDEX) can provide additive anti-hyperalgesic, anti-inflammatory and antioxidant effects without increasing cardiovascular risk when each is dosed within its established therapeutic window.
In this protocol, a weight-adjusted intra-operative infusion of lidocaine plus dexmedetomidine is administered during bariatric surgery and compared with each single agent and saline. Peri-operative venous samples are collected for mechanistic profiling of systemic inflammatory and redox responses, and patient-reported pain is captured after surgery using a validated instrument. Haemodynamic parameters are continuously monitored to detect potential lidocaine toxicity or dexmedetomidine-related bradycardia and hypotension; predefined rescue algorithms are applied if thresholds are exceeded.
The study is designed to clarify whether the LIDEX combination can blunt the acute inflammatory-oxidative surge thought to drive sustained pain and metabolic stress after bariatric surgery, thereby informing future enhanced-recovery protocols that integrate multimodal analgesia with metabolic optimisation strategies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lidocaine Infusion (LID)
Intra-operative IV lidocaine 1 % at ≈ 1.5 mg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹). Infusion starts after induction and stops at skin closure; no post-operative infusion.
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.
Dexmedetomidine Infusion (DEX)
Intra-operative IV dexmedetomidine ≈ 0.3 µg·kg-¹·h-¹ (0.3 mL·kg-¹·h-¹) without loading dose, from induction to skin closure.
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.
Lidocaine + Dexmedetomidine (LIDEX)
Concurrent IV lidocaine 1 % (1.5 mg·kg-¹·h-¹) plus dexmedetomidine (0.3 µg·kg-¹·h-¹) in the same syringe, administered from induction to skin closure.
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.
Saline Placebo
IV 0.9 % saline at 0.3 mL·kg-¹·h-¹ for the same duration as active arms; syringe identical in appearance.
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.
Interventions
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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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
60 Years
ALL
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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Dulce Maria Rascon Martinez
Clinical Research Physician
Principal Investigators
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Dulce María Rascón Martínez, Prof MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Arnulfo Calixto Flores, Prof MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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R-2025-3601-197
Identifier Type: -
Identifier Source: org_study_id
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