Modulation of the Inflammatory Response in Bariatric Surgery (MRICBx3)

April 4, 2025 updated by: HIPÓLITO LABANDEYRA GONZALEZ, Hospital HM Nou Delfos

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, double-blind, comparative observational study designed to assess the perioperative inflammatory response in patients undergoing bariatric surgery under three anesthetic techniques: opioid-free anesthesia (OFA), opioid-based intravenous anesthesia (OBA-IV), and opioid-based inhalational anesthesia (OBA-Inh).

A total of 90 patients scheduled for elective laparoscopic bariatric surgery will be enrolled and randomized using computer-generated allocation into three equal groups (n=30 each). Allocation concealment will be maintained using sealed opaque envelopes. Blinding will involve both the patients and outcome assessors; anesthesiologists administering the interventions will not be blinded due to the nature of the techniques.

The study's primary focus is to evaluate the perioperative modulation of inflammation through quantification of biomarkers including interleukin-6 (IL-6), C-reactive protein (CRP), serum cortisol, leukocyte count (WBC), erythrocyte sedimentation rate (ESR) and lactate. Heart rate variability (HRV) will be continuously monitored as a surrogate marker for autonomic modulation of the inflammatory response.

Biomarkers will be sampled at three time points: preoperative baseline (T0), at the end of surgery (T1), and 24 hours postoperatively (T2). HRV data will be collected from induction to the end of surgical intervention using a non invasive monitoring system with time- and frequency-domain analysis.

Secondary outcomes include intraoperative and postoperative analgesic consumption, pain intensity assessed by visual analog scale (VAS), sedation scores using the Ramsay Agitation-Sedation Scale (RASS), incidence of opioid-related side effects (nausea, vomiting, respiratory depression), patient satisfaction (via validated questionnaire), and length of hospital stay.

Sample size was calculated based on preliminary data detecting a clinically significant difference in IL-6 levels, assuming an alpha of 0.05 and power of 0.8. Data will be analyzed using ANOVA or Kruskal-Wallis test for continuous variables, chi-square for categorical variables, and multivariate regression models to adjust for potential confounders.

This study aims to identify anesthetic strategies that minimize systemic inflammation and autonomic dysregulation in the bariatric surgical population, with potential applications in broader surgical settings.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08023
        • Recruiting
        • Hospital HM Nou Delfos
        • Contact:
        • Contact:
          • Gregory Contreras-Pérez, Anesthesiologist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Opioid-Free Anesthesia (OFA)
Patients in this group will receive opioid-free anesthesia (OFA) using a multimodal analgesic approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids will be administered. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and heart rate variability (HRV) will be measured to assess the inflammatory response.
Procedure: Opioid-Free Anesthesia (OFA)
Opioid-free anesthesia using a multimodal approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids are administered.
Other Names:
  • Multimodal Opioid-Free Anesthesia
Opioid-Based Anesthesia - Intravenous (OBA-IV)
Patients in this group will receive opioid-based intravenous anesthesia (OBA-IV) with propofol, remifentanil, and neuromuscular blockade. Standard opioid-based analgesia will be administered intraoperatively. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and HRV will be assessed to compare inflammatory responses between opioid-based and opioid-free techniques.
Procedure: Opioid-Based Intravenous Anesthesia (OBA-IV)
Standard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade.
Other Names:
  • IV Opioid-Based Anesthesia
Opioid-Based Anesthesia - Inhalational (OBA-Inh)
Patients in this group will receive opioid-based inhalational anesthesia (OBA-Inh) using sevoflurane, remifentanil, and neuromuscular blockade. Standard opioid-based analgesia will be used intraoperatively. Inflammatory biomarkers (IL-6, PCR, cortisol, WBC, VSG) and HRV will be analyzed to evaluate differences in the inflammatory response among the three anesthetic techniques.
Procedure: Opioid-Based Inhalational Anesthesia (OBA-Inh)
Standard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade.
Other Names:
  • Inhalational Opioid-Based Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum IL-6 Level
Time Frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement of interleukin-6 (IL-6) concentration in pg/mL to evaluate inflammatory response.
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
C-reactive Protein (CRP) Level
Time Frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement in mg/L to assess systemic inflammation.
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Serum Cortisol Level
Time Frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement in μg/dL.
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Heart Rate Variability (HRV) as an Inflammatory Marker
Time Frame: Collected 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
Collected continuosly from the induction of the anesthesia until the end of surgery
Serum Lactate Level
Time Frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement in mmol/L as a marker of metabolic response.
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Erythrocyte Sedimentation Rate (ESR)
Time Frame: Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Measurement of ESR in mm/h to assess systemic inflammation.
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.
Differential White blood Cell count (WBC).
Time Frame: 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.
Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Evaluation Using Visual Analog Scale (VAS)
Time Frame: hourly during the first 4 hours post surgery in the recovery area, and at 12 and 24 hours in the hospitalization ward
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.
hourly during the first 4 hours post surgery in the recovery area, and at 12 and 24 hours in the hospitalization ward
Postoperative Sedation Level Using Ramsay Sedation Scale
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
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.
immediately after surgery, and hourly during the first 4 hours in the recovery area, and at 12 and 24 hours in the hospitalization ward
Incidence of Postoperative Complications
Time Frame: 24 hours post-surgery.
Measurement of total hospital stay (in days) after surgery.
24 hours post-surgery.
Patient Satisfaction with Anesthetic Technique
Time Frame: 24 hours post-surgery.
Evaluation of patient satisfaction using a standardized 5-point Likert scale questionnaire (1 = very dissatisfied; 5 = very satisfied) regarding anesthesia and overall recovery experience.
24 hours post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital HM Nou Delfos

Investigators

  • Principal Investigator: Gregory Contreras-Pérez, Anesthesiologist, Hospital HM Nou Delfos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

December 2, 2025

Study Completion (Estimated)

December 2, 2025

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25.02.2467-GHM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to privacy regulations and ethical considerations. Data will only be accessible to the research team and authorized personnel as per institutional and regulatory guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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