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

Summary

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.

Conditions

• Morbid Obesity Requiring Bariatric Surgery
• Postoperative Pain
• Postoperative Pain Management
• Postoperative Analgesia
• Postoperative Adjuvant Treatment
• Postoperative Inflammatory Markers
• Postoperative Inflammatory Response

Interventions

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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social

  lead OTHER_GOV

Principal Investigators

• Dulce María Rascón Martínez, Prof MD, MSc · Instituto Mexicano del Seguro Social

• Arnulfo Calixto Flores, Prof MD, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-06

Primary Completion

2027-05-01

Completion

2027-07-01

Countries

• Mexico

Study Locations