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New treatment option for Morbid Obesity Requiring Bariatric Surgery
Official title Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery.
ClinicalTrials.gov ID: NCT07073846
What this study is testing
What is Intravenous Lidocaine infusion + Standard Anesthesia?
Intravenous Lidocaine infusion + Standard Anesthesia is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for morbid obesity requiring bariatric surgery.
Also referred to as Xylocaine®, Lignocaine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)?
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- Use of any loco-regional anaesthetic technique during the peri-operative period (transversus abdominis plane, paravertebral, spinal, epidural...
- 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...
- Estimated glomerular filtration rate (eGFR) \< 60 mL min-¹ 1.73 m-² (moderate-to-severe renal impairment).
See the full eligibility 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
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.