Modulation of the Inflammatory Response in Bariatric Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorHospital HM Nou Delfos

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Opioid-Free Anesthesia (OFA)

    Procedure/Surgery

    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/Surgery

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

  • Opioid-Based Inhalational Anesthesia (OBA-Inh)

    Procedure/Surgery

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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Opioid-Free Anesthesia (OFA)1 intervention
Group B: Opioid-Based Anesthesia - Intravenous (OBA-IV)1 intervention
Group C: Opioid-Based Anesthesia - Inhalational (OBA-Inh)1 intervention

Trial outcomes

Primary outcomes

1

Serum IL-6 Level

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

Time frame
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
2

C-reactive Protein (CRP) Level

Measurement in mg/L to assess systemic inflammation.

Time frame
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
3

Serum Cortisol Level

Measurement in μg/dL.

Time frame
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
4

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

Time frame
Collected continuosly from the induction of the anesthesia until the end of surgery

Secondary outcomes

1

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.

Time frame
hourly during the first 4 hours post surgery in the recovery area, and at 12 and 24 hours in the hospitalization ward
2

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.

Time frame
immediately after surgery, and hourly during the first 4 hours in the recovery area, and at 12 and 24 hours in the hospitalization ward
3

Incidence of Postoperative Complications

Measurement of total hospital stay (in days) after surgery.

Time frame
24 hours post-surgery.
4

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.

Time frame
24 hours post-surgery.

Other outcomes

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