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

Launched by INSTITUTO MEXICANO DEL SEGURO SOCIAL · Jul 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether giving a combination of two medicines, lidocaine and dexmedetomidine, through a vein during weight-loss surgery (called bariatric surgery) can help reduce pain, inflammation, and stress in the body after the operation. The researchers want to see if this combination works better than using either medicine alone or a placebo (a saltwater solution with no medicine). To find out, they will look at patients’ pain levels 24 hours after surgery and check certain substances in the blood that show how much inflammation and stress the body is experiencing.

Adults between 18 and 60 years old who are having planned laparoscopic bariatric surgery and are generally healthy enough for surgery (with specific physical health ratings) may be eligible to join. During the study, participants will receive one of the study treatments through an IV while they are having surgery. They will also have three small blood samples taken—before surgery, right after, and three hours later—to measure inflammation and stress markers. Finally, they will fill out a short questionnaire about their pain 24 hours after surgery. This study aims to find better ways to manage pain and recovery after bariatric surgery, which could help patients feel more comfortable and heal faster.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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 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).