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Clinical Trials in Spain / NCT06915558
Recruiting Observational

Modulation of the Inflammatory Response in Bariatric Surgery

NCT06915558 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital HM Nou Delfos
Phase
Observational
Started
2024-12-02
Last updated
2025-04-08

Condition(s) studied

ObesityBariatric Surgery CandidateInflammationPostoperative PainOpioid-Free AnesthesiaHeart Rate Variability

Investigational drug(s) / intervention(s)

Opioid-Free Anesthesia (OFA)Opioid-Based Intravenous Anesthesia (OBA-IV)Opioid-Based Inhalational Anesthesia (OBA-Inh)

Opioid-Free Anesthesia (OFA): Opioid-free anesthesia using a multimodal approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids are administered.

Opioid-Based Intravenous Anesthesia (OBA-IV): Standard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade.

Opioid-Based Inhalational Anesthesia (OBA-Inh): Standard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade.

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Patients scheduled for bariatric surgery. * Age 18-65 years. * BMI ≥ 30 kg/m². * ASA physical status II-III. Exclusion Criteria: * Pregnancy or breastfeeding. * Chronic opioid use before surgery. * Severe renal or hepatic failure. * Uncontrolled psychiatric disorders. * Significant intraoperative complications requiring protocol deviation.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital HM Nou Delfos Barcelona Barcelona Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06915558 on ClinicalTrials.gov ↗ ← All trials in Spain