RecruitingNCT06915558

Modulation of the Inflammatory Response in Bariatric Surgery

Modulation of the Inflammatory Response to Surgical Trauma: Comparison of Three Anesthetic Techniques in Bariatric Surgery Patients


Sponsor

Hospital HM Nou Delfos

Enrollment

90 participants

Start Date

Dec 2, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

This study will evaluate how different anesthesia techniques affect inflammation after bariatric surgery. Patients will be randomly assigned to receive one of three approaches: opioid-free anesthesia, intravenous anesthesia with opioids, or inhalational anesthesia with opioids. The study will measure blood levels of inflammation-related substances (such as IL-6, CRP, cortisol, ESR , WBC and lactate) at several time points before and after surgery. Heart rate variability will also be monitored as an indicator of the body's stress response. The results may help identify anesthesia strategies that reduce inflammation and improve recovery in patients undergoing bariatric surgery.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • Patients scheduled for bariatric surgery.
  • Age 18-65 years.
  • BMI ≥ 30 kg/m².
  • ASA physical status II-III.

Exclusion Criteria5

  • Pregnancy or breastfeeding.
  • Chronic opioid use before surgery.
  • Severe renal or hepatic failure.
  • Uncontrolled psychiatric disorders.
  • Significant intraoperative complications requiring protocol deviation.

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Interventions

PROCEDUREOpioid-Free Anesthesia (OFA)

Opioid-free anesthesia using a multimodal approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids are administered.

PROCEDUREOpioid-Based Intravenous Anesthesia (OBA-IV)

Standard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade.

PROCEDUREOpioid-Based Inhalational Anesthesia (OBA-Inh)

Standard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade.


Locations(1)

Hospital HM Nou Delfos

Barcelona, Barcelona, Spain

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NCT06915558


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