Clinical trial

Modulation of the Inflammatory Response in Bariatric Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT06915558

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Bariatric Surgery Candidate, Inflammation, Postoperative Pain, Opioid-Free Anesthesia, Heart Rate Variability

Full registry criteria

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.

Treatments and study arms

Opioid-Free Anesthesia (OFA)

Procedure

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)

Procedure

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

Opioid-Based Inhalational Anesthesia (OBA-Inh)

Procedure

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

Primary outcomes

Serum IL-6 LevelPreoperative (baseline), immediately after surgery, and 24 hours post-surgery.

Measurement of interleukin-6 (IL-6) concentration in pg/mL to evaluate inflammatory response.

C-reactive Protein (CRP) LevelPreoperative (baseline), immediately after surgery, and 24 hours post-surgery.

Measurement in mg/L to assess systemic inflammation.

Serum Cortisol LevelPreoperative (baseline), immediately after surgery, and 24 hours post-surgery.

Measurement in μg/dL.

Heart Rate Variability (HRV) as an Inflammatory MarkerCollected continuosly from the induction of the anesthesia until the end of surgery

Heart Rate Variability (HRV) as an Inflammatory Marker and its correlation with blood levels of inflammatory markers Heart Rate Variability (HRV) as an Indicator of Inflammatory Response

Serum Lactate LevelPreoperative (baseline), immediately after surgery, and 24 hours post-surgery.

Measurement in mmol/L as a marker of metabolic response.

Erythrocyte Sedimentation Rate (ESR)Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.

Measurement of ESR in mm/h to assess systemic inflammation.

Differential White blood Cell count (WBC).Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.

Measurement of total white blood cell count in peripheral blood, expressed in thousands of cells per microliter (10³/μL). Assessment of the percentage distribution of white blood cell subtypes, including neutrophils, lymphocytes, monocytes, eosinophils, and basophils, expressed as a percentage of total leukocytes.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital HM Nou Delfos🇪🇸 Barcelona, Barcelona, Spain

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Hipolito Labandeyra Gonzalez, AnesthesiologistContact

Email · Call +34696055181

Gregory Contreras-Pérez, AnesthesiologistPrincipal Investigator