About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for bariatric surgery.
Age 18-65 years.
BMI ≥ 30 kg/m².
ASA physical status II-III.
Disqualifiers
Pregnancy or breastfeeding.
Chronic opioid use before surgery.
Severe renal or hepatic failure.
Uncontrolled psychiatric disorders.
Trial population
The study population consists of adult patients undergoing elective bariatric surgery at HM Nou Delfos Hospital. Patients will be selected according to specific inclusion and exclusion criteria to ensure homogeneous groups for the comparison of inflammatory response to different anesthetic techniques. All participants will undergo preoperative screening, intraoperative monitoring, and postoperative follow-up to evaluate primary and secondary outcomes.
Trial design
Cohort
Prospective
Treatments tested in this trial
Opioid-Free Anesthesia (OFA)
Procedure/SurgeryOpioid-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/SurgeryStandard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade.
Opioid-Based Inhalational Anesthesia (OBA-Inh)
Procedure/SurgeryStandard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade.
Treatment groups
Trial outcomes
Primary outcomes
Serum IL-6 Level
Measurement of interleukin-6 (IL-6) concentration in pg/mL to evaluate inflammatory response.
C-reactive Protein (CRP) Level
Measurement in mg/L to assess systemic inflammation.
Serum Cortisol Level
Measurement in μg/dL.
Heart Rate Variability (HRV) as an Inflammatory Marker
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
Secondary outcomes
Postoperative Pain Evaluation Using Visual Analog Scale (VAS)
Assessment of pain intensity using the Visual Analog Scale (VAS), a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Postoperative Sedation Level Using Ramsay Sedation Scale
Evaluation of sedation using the Ramsay Sedation Scale, which ranges from 1 (anxious and agitated) to 6 (no response to stimulus). Higher scores indicate deeper levels of sedation.
Incidence of Postoperative Complications
Measurement of total hospital stay (in days) after surgery.
Patient Satisfaction with Anesthetic Technique
Evaluation of patient satisfaction using a standardized 5-point Likert scale questionnaire (1 = very dissatisfied; 5 = very satisfied) regarding anesthesia and overall recovery experience.
Sponsors and contacts
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