Modulation of the Inflammatory Response in Bariatric Surgery
NCT ID: NCT06915558
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2024-12-02
2025-12-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Opioid-Free Anesthesia (OFA)
Opioid-free anesthesia using a multimodal approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids are administered.
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.
Opioid-Based Intravenous Anesthesia (OBA-IV)
Standard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade.
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.
Opioid-Based Inhalational Anesthesia (OBA-Inh)
Standard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade.
Interventions
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Opioid-Free Anesthesia (OFA)
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)
Standard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade.
Opioid-Based Inhalational Anesthesia (OBA-Inh)
Standard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-65 years.
* BMI ≥ 30 kg/m².
* ASA physical status II-III.
Exclusion Criteria
* Chronic opioid use before surgery.
* Severe renal or hepatic failure.
* Uncontrolled psychiatric disorders.
* Significant intraoperative complications requiring protocol deviation.
18 Years
65 Years
ALL
No
Sponsors
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Hospital HM Nou Delfos
OTHER
Responsible Party
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HIPÓLITO LABANDEYRA GONZALEZ
Anesthesiologist
Principal Investigators
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Gregory Contreras-Pérez, Anesthesiologist
Role: PRINCIPAL_INVESTIGATOR
Hospital HM Nou Delfos
Locations
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Hospital HM Nou Delfos
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Gregor MF, Hotamisligil GS. Inflammatory mechanisms in obesity. Annu Rev Immunol. 2011;29:415-45. doi: 10.1146/annurev-immunol-031210-101322.
Other Identifiers
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25.02.2467-GHM
Identifier Type: -
Identifier Source: org_study_id
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