Modulation of the Inflammatory Response in Bariatric Surgery

NCT06915558 | Recruiting

• 1 other identifier: 25.02.2467-GHM
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Bariatric Surgery Candidate; Inflammation; Postoperative Pain; Opioid-Free Anesthesia; Heart Rate Variability

Keywords

Opioid-Free Anesthesia; Opioid-Based Anesthesia; Inflammatory Markers; Surgical Stress Response; heart rate variability

Outcome Measures

Primary Outcomes (7)

• Serum IL-6 Level

  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

  Measurement in mg/L to assess systemic inflammation.

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

• Serum Cortisol Level

  Measurement in μg/dL.

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

• 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

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

• Serum Lactate Level

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

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

• Erythrocyte Sedimentation Rate (ESR)

  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).

  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 Outcomes (4)

• Postoperative Pain Evaluation Using Visual Analog Scale (VAS)

  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

  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

  24 hours post-surgery.

• Patient Satisfaction with Anesthetic Technique

  24 hours post-surgery.

Study Arms (3)

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-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)

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)

Interventions

Opioid-Free Anesthesia (OFA) PROCEDURE

Opioid-free anesthesia using a multimodal approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids are administered.

Also known as: Multimodal Opioid-Free Anesthesia

Opioid-Free Anesthesia (OFA)

Opioid-Based Intravenous Anesthesia (OBA-IV) PROCEDURE

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

Also known as: IV Opioid-Based Anesthesia

Opioid-Based Anesthesia - Intravenous (OBA-IV)

Opioid-Based Inhalational Anesthesia (OBA-Inh) PROCEDURE

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

Also known as: Inhalational Opioid-Based Anesthesia

Opioid-Based Anesthesia - Inhalational (OBA-Inh)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients scheduled for bariatric surgery.
• Age 18-65 years.
• BMI ≥ 30 kg/m².
• ASA physical status II-III.

You may not qualify if:

• Pregnancy or breastfeeding.
• Chronic opioid use before surgery.
• Severe renal or hepatic failure.
• Uncontrolled psychiatric disorders.
• Significant intraoperative complications requiring protocol deviation.

Sponsors & Collaborators

• Hospital HM Nou Delfos: lead

Study Sites (1)

Hospital HM Nou Delfos

Barcelona, Barcelona, 08023, Spain

RECRUITING

Related Publications (13)

• Heil LBB, Silva PL, Pelosi P, Rocco PRM. Immunomodulatory effects of anesthetics in obese patients. World J Crit Care Med. 2017 Aug 4;6(3):140-152. doi: 10.5492/wjccm.v6.i3.140. eCollection 2017 Aug 4.

  PMID: 28828299 BACKGROUND

• Alsumali A, Eguale T, Bairdain S, Samnaliev M. Cost-Effectiveness Analysis of Bariatric Surgery for Morbid Obesity. Obes Surg. 2018 Aug;28(8):2203-2214. doi: 10.1007/s11695-017-3100-0.

  PMID: 29335933 BACKGROUND

• Lin YT, Wu HT, Tsao J, Yien HW, Hseu SS. Time-varying spectral analysis revealing differential effects of sevoflurane anaesthesia: non-rhythmic-to-rhythmic ratio. Acta Anaesthesiol Scand. 2014 Feb;58(2):157-67. doi: 10.1111/aas.12251.

  PMID: 24410106 BACKGROUND

• Bonhomme V, Uutela K, Hans G, Maquoi I, Born JD, Brichant JF, Lamy M, Hans P. Comparison of the surgical Pleth Index with haemodynamic variables to assess nociception-anti-nociception balance during general anaesthesia. Br J Anaesth. 2011 Jan;106(1):101-11. doi: 10.1093/bja/aeq291. Epub 2010 Nov 4.

  PMID: 21051493 BACKGROUND

• Wennervirta J, Hynynen M, Koivusalo AM, Uutela K, Huiku M, Vakkuri A. Surgical stress index as a measure of nociception/antinociception balance during general anesthesia. Acta Anaesthesiol Scand. 2008 Sep;52(8):1038-45. doi: 10.1111/j.1399-6576.2008.01687.x.

  PMID: 18840101 BACKGROUND

• Lisowska B, Jakubiak J, Siewruk K, Sady M, Kosson D. Which idea is better with regard to immune response? Opioid anesthesia or opioid free anesthesia. J Inflamm Res. 2020 Nov 5;13:859-869. doi: 10.2147/JIR.S275986. eCollection 2020.

  PMID: 33177861 BACKGROUND

• Campos-Perez W, Ramirez-Plascencia L, Perez-Robles M, Rivera-Valdes JJ, Sanchez-Munoz P, Perez-Vargas L, Gonzalez-Landeros D, Cuevas JHM, Martinez-Lopez E. A comparison of opioid-containing anesthesia versus opioid-free anesthesia using the Cortinez-Sepulveda model on differential cytokine responses in obese patients undergoing gastric bypass surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Sep 16;22(1):294. doi: 10.1186/s12871-022-01838-8.

  PMID: 36114460 BACKGROUND

• Ahmed SA, Abdelghany MS, Afandy ME. The effect of opioid-free anesthesia on the post-operative opioid consumption in laparoscopic bariatric surgeries: A randomized controlled double-blind study. J Opioid Manag. 2022 Jan-Feb;18(1):47-56. doi: 10.5055/jom.2022.0694.

  PMID: 35238013 BACKGROUND

• Schneemilch CE, Ittenson A, Ansorge S, Hachenberg T, Bank U. Effect of 2 anesthetic techniques on the postoperative proinflammatory and anti-inflammatory cytokine response and cellular immune function to minor surgery. J Clin Anesth. 2005 Nov;17(7):517-27. doi: 10.1016/j.jclinane.2004.12.017.

  PMID: 16297751 BACKGROUND

• Lin E, Calvano SE, Lowry SF. Inflammatory cytokines and cell response in surgery. Surgery. 2000 Feb;127(2):117-26. doi: 10.1067/msy.2000.101584.

  PMID: 10686974 BACKGROUND

• Schumann R. Anaesthesia for bariatric surgery. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):83-93. doi: 10.1016/j.bpa.2010.12.006.

  PMID: 21516916 BACKGROUND

• Ellulu MS, Patimah I, Khaza'ai H, Rahmat A, Abed Y. Obesity and inflammation: the linking mechanism and the complications. Arch Med Sci. 2017 Jun;13(4):851-863. doi: 10.5114/aoms.2016.58928. Epub 2016 Mar 31.

  PMID: 28721154 BACKGROUND

• Gregor MF, Hotamisligil GS. Inflammatory mechanisms in obesity. Annu Rev Immunol. 2011;29:415-45. doi: 10.1146/annurev-immunol-031210-101322.

  PMID: 21219177 BACKGROUND

MeSH Terms

Conditions

Obesity; Inflammation; Pain, Postoperative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations

Study Officials

• Gregory Contreras-Pérez, Anesthesiologist

  Hospital HM Nou Delfos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hipolito Labandeyra Gonzalez, Anesthesiologist

CONTACT

+34696055181; hipolitolabandeyra@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 8, 2025
• Study Start: December 2, 2024
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)