Actively Recruiting
Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
Led by Instituto Mexicano del Seguro Social · Updated on 2025-11-28
104
Participants Needed
2
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 - 60 years
- Male or female
- Scheduled for elective laparoscopic bariatric surgery
- Expected hospital stay of at least 24 hours post-surgery
- ASA physical status II or III
You will not qualify if you...
- Use of any loco-regional anesthesia during the peri-operative period
- Current substance abuse or illicit drug use
- Previous abdominal surgery within the last 6 months
- Known allergy to lidocaine, dexmedetomidine, amide local anesthetics, or alpha-2 adrenergic agonists
- Congestive heart failure, significant bradyarrhythmia, or certain heart blocks without pacemaker
- Severe hypotension or current use of Class I/III anti-arrhythmic drugs
- Moderate-to-severe renal impairment (eGFR < 60 mL/min/1.73 m2)
- Severe liver impairment (Child-Pugh C)
- Pregnancy or breastfeeding
- Chronic opioid use over 30 mg oral morphine equivalents daily for more than 4 weeks
- Active seizure disorder, myasthenia gravis, or other neurological conditions contra-indicating lidocaine infusion
- Unable to communicate or unwilling to complete the questionnaire
- Participation in another interventional study within the past 30 days
- Conversion to open surgery during operation
- Insufficient biological sample for biomarker analysis
- Premature stopping of study drug during surgery due to complications preventing safety assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital de Especialidades Centro Medico Nacional Siglo XXI
Mexico City, Mexico City, Mexico, 06720
Actively Recruiting
2
Unidad Médica de Alta Especialidad Hospital de Especialidades del Centro Médico Nacional Siglo XXI
Mexico City, Mexico City, Mexico, 06720
Actively Recruiting
Research Team
D
Dulce M Rascón Martínez, Prof MD, MSc
CONTACT
A
Arnulfo Calixto Flores, Prof MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here