Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-31 @ 8:35 PM
Study NCT ID:
NCT06915558
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of the Inflammatory Response in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum IL-6 Level', 'timeFrame': 'Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.', 'description': 'Measurement of interleukin-6 (IL-6) concentration in pg/mL to evaluate inflammatory response.'}, {'measure': 'C-reactive Protein (CRP) Level', 'timeFrame': 'Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.', 'description': 'Measurement in mg/L to assess systemic inflammation.'}, {'measure': 'Serum Cortisol Level', 'timeFrame': 'Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.', 'description': 'Measurement in μg/dL.'}, {'measure': 'Heart Rate Variability (HRV) as an Inflammatory Marker', 'timeFrame': 'Collected continuosly from the induction of the anesthesia until the end of surgery', 'description': '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'}, {'measure': 'Serum Lactate Level', 'timeFrame': 'Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.', 'description': 'Measurement in mmol/L as a marker of metabolic response.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.', 'description': 'Measurement of ESR in mm/h to assess systemic inflammation.'}, {'measure': 'Differential White blood Cell count (WBC).', 'timeFrame': 'Preoperative (baseline), immediately after surgery, and 24 hours post-surgery.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Evaluation Using Visual Analog Scale (VAS)', 'timeFrame': 'hourly during the first 4 hours post surgery in the recovery area, and at 12 and 24 hours in the hospitalization ward', 'description': '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.'}, {'measure': 'Postoperative Sedation Level Using Ramsay Sedation Scale', 'timeFrame': 'immediately after surgery, and hourly during the first 4 hours in the recovery area, and at 12 and 24 hours in the hospitalization ward', 'description': '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.'}, {'measure': 'Incidence of Postoperative Complications', 'timeFrame': '24 hours post-surgery.', 'description': 'Measurement of total hospital stay (in days) after surgery.'}, {'measure': 'Patient Satisfaction with Anesthetic Technique', 'timeFrame': '24 hours post-surgery.', 'description': 'Evaluation of patient satisfaction using a standardized 5-point Likert scale questionnaire (1 = very dissatisfied; 5 = very satisfied) regarding anesthesia and overall recovery experience.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid-Free Anesthesia', 'Opioid-Based Anesthesia', 'Inflammatory Markers', 'Surgical Stress Response', 'heart rate variability'], 'conditions': ['Obesity', 'Bariatric Surgery Candidate', 'Inflammation', 'Postoperative Pain', 'Opioid-Free Anesthesia', 'Heart Rate Variability']}, 'referencesModule': {'references': [{'pmid': '28828299', 'type': 'BACKGROUND', 'citation': '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': '29335933', 'type': 'BACKGROUND', 'citation': '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': '24410106', 'type': 'BACKGROUND', 'citation': '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': '21051493', 'type': 'BACKGROUND', 'citation': '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': '18840101', 'type': 'BACKGROUND', 'citation': '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': '33177861', 'type': 'BACKGROUND', 'citation': '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': '36114460', 'type': 'BACKGROUND', 'citation': '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': '35238013', 'type': 'BACKGROUND', 'citation': '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': '16297751', 'type': 'BACKGROUND', 'citation': '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': '10686974', 'type': 'BACKGROUND', 'citation': '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': '21516916', 'type': 'BACKGROUND', 'citation': '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': '28721154', 'type': 'BACKGROUND', 'citation': "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': '21219177', 'type': 'BACKGROUND', 'citation': 'Gregor MF, Hotamisligil GS. Inflammatory mechanisms in obesity. Annu Rev Immunol. 2011;29:415-45. doi: 10.1146/annurev-immunol-031210-101322.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe results may help identify anesthesia strategies that reduce inflammation and improve recovery in patients undergoing bariatric surgery.", 'detailedDescription': "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).\n\nA 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.\n\nThe 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.\n\nBiomarkers 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.\n\nSecondary 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.\n\nSample 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for bariatric surgery.\n* Age 18-65 years.\n* BMI ≥ 30 kg/m².\n* ASA physical status II-III.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Chronic opioid use before surgery.\n* Severe renal or hepatic failure.\n* Uncontrolled psychiatric disorders.\n* Significant intraoperative complications requiring protocol deviation.'}, 'identificationModule': {'nctId': 'NCT06915558', 'acronym': 'MRICBx3', 'briefTitle': 'Modulation of the Inflammatory Response in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital HM Nou Delfos'}, 'officialTitle': 'Modulation of the Inflammatory Response to Surgical Trauma: Comparison of Three Anesthetic Techniques in Bariatric Surgery Patients', 'orgStudyIdInfo': {'id': '25.02.2467-GHM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Opioid-Free Anesthesia (OFA)', 'description': '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.', 'interventionNames': ['Procedure: Opioid-Free Anesthesia (OFA)']}, {'label': 'Opioid-Based Anesthesia - Intravenous (OBA-IV)', 'description': '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.', 'interventionNames': ['Procedure: Opioid-Based Intravenous Anesthesia (OBA-IV)']}, {'label': 'Opioid-Based Anesthesia - Inhalational (OBA-Inh)', 'description': '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.', 'interventionNames': ['Procedure: Opioid-Based Inhalational Anesthesia (OBA-Inh)']}], 'interventions': [{'name': 'Opioid-Free Anesthesia (OFA)', 'type': 'PROCEDURE', 'otherNames': ['Multimodal Opioid-Free Anesthesia'], 'description': 'Opioid-free anesthesia using a multimodal approach, including dexmedetomidine, lidocaine, ketamine, and magnesium sulfate. No intraoperative opioids are administered.', 'armGroupLabels': ['Opioid-Free Anesthesia (OFA)']}, {'name': 'Opioid-Based Intravenous Anesthesia (OBA-IV)', 'type': 'PROCEDURE', 'otherNames': ['IV Opioid-Based Anesthesia'], 'description': 'Standard opioid-based intravenous anesthesia using propofol, remifentanil, and neuromuscular blockade.', 'armGroupLabels': ['Opioid-Based Anesthesia - Intravenous (OBA-IV)']}, {'name': 'Opioid-Based Inhalational Anesthesia (OBA-Inh)', 'type': 'PROCEDURE', 'otherNames': ['Inhalational Opioid-Based Anesthesia'], 'description': 'Standard opioid-based inhalational anesthesia using sevoflurane, remifentanil, and neuromuscular blockade.', 'armGroupLabels': ['Opioid-Based Anesthesia - Inhalational (OBA-Inh)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08023', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Hipolito Labandeyra Gonzalez, Anesthesiologist', 'role': 'CONTACT', 'email': 'hipolitolabandeyra@gmail.com', 'phone': '+34696055181'}, {'name': 'Gregory Contreras-Pérez, Anesthesiologist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital HM Nou Delfos', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Hipolito Labandeyra Gonzalez, Anesthesiologist', 'role': 'CONTACT', 'email': 'hipolitolabandeyra@gmail.com', 'phone': '+34696055181'}], 'overallOfficials': [{'name': 'Gregory Contreras-Pérez, Anesthesiologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital HM Nou Delfos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital HM Nou Delfos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'HIPÓLITO LABANDEYRA GONZALEZ', 'investigatorAffiliation': 'Hospital HM Nou Delfos'}}}}