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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
Hospital de Especialidades Centro Medico Nacional Siglo XXI
RECRUITING
Mexico City
Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI
RECRUITING
Mexico City
Contact Information
Primary
Dulce M Rascón Martínez, Prof MD, MSc
dradulcerascon@gmail.com
+ 52 55 5627 6900
Backup
Arnulfo Calixto Flores, Prof MD, PhD
drrufo@hotmail.com
+ 52 55 5627 6900
Time Frame
Start Date: 2025-10-06
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 104
Treatments
Active_comparator: 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.
Active_comparator: 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.
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Instituto Mexicano del Seguro Social

This content was sourced from clinicaltrials.gov