Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT07075302
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2025-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OFA vs OBA in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2025-07-11', 'studyFirstSubmitQcDate': '2025-07-11', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total postoperative morphine consumption (mg)', 'timeFrame': 'From 0 to 48 hours after surgery', 'description': 'Cumulative amount of morphine (in milligrams) administered within the first 48 hours after surgery, as recorded in the post-anesthesia care unit and inpatient medical records.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity (VAS)', 'timeFrame': 'At 1, 2, 4, 24, and 48 hours postoperatively', 'description': 'Pain evaluated using the Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain), both at rest and with movement.'}, {'measure': 'Sedation level (RAMSAY scale)', 'timeFrame': 'From 0 to 48 hours after surgery', 'description': 'Sedation assessed using the Ramsay Sedation Scale, ranging from 1 (anxious/agitated) to 6 (no response to stimuli).'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'Number of patients experiencing side effects such as nausea, vomiting, pruritus, hypotension, bradycardia, ileus, or urinary retention.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From surgery until discharge (up to 7 days)', 'description': 'Total duration of hospital stay in days, calculated from the day of surgery to discharge date.'}, {'measure': 'Time to awakening', 'timeFrame': 'Intraoperative period until recovery (measured at end of surgery)', 'description': 'Time in minutes from the end of surgery until patient opens eyes or responds to verbal commands.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid-Free Anesthesia', 'Bariatric Surgery', 'opioid-based anesthesia', 'morphine consumption', 'TIVA', 'multimodal analgesia'], 'conditions': ['Obesity', 'Postoperative Pain', 'Bariatric Surgery', 'Opioid-free Anesthesia']}, 'referencesModule': {'references': [{'pmid': '33423410', 'type': 'BACKGROUND', 'citation': 'Kumar A, Kohli A. Comeback of ketamine: resurfacing facts and dispelling myths. Korean J Anesthesiol. 2021 Apr;74(2):103-114. doi: 10.4097/kja.20663. Epub 2021 Jan 11.'}, {'pmid': '7502015', 'type': 'BACKGROUND', 'citation': 'Brannian JD, McCulloh DH. Gonadotropin control of follicle and oocyte maturation: implications for ovulation induction. S D J Med. 1995 Oct;48(10):335-9.'}, {'pmid': '29300271', 'type': 'BACKGROUND', 'citation': 'Roesslein M, Chung F. Obstructive sleep apnoea in adults: peri-operative considerations: A narrative review. Eur J Anaesthesiol. 2018 Apr;35(4):245-255. doi: 10.1097/EJA.0000000000000765.'}, {'pmid': '15684259', 'type': 'BACKGROUND', 'citation': 'Hofer RE, Sprung J, Sarr MG, Wedel DJ. Anesthesia for a patient with morbid obesity using dexmedetomidine without narcotics. Can J Anaesth. 2005 Feb;52(2):176-80. doi: 10.1007/BF03027725.'}, {'pmid': '20881501', 'type': 'BACKGROUND', 'citation': 'Mantz J, Josserand J, Hamada S. Dexmedetomidine: new insights. Eur J Anaesthesiol. 2011 Jan;28(1):3-6. doi: 10.1097/EJA.0b013e32833e266d.'}, {'pmid': '19713256', 'type': 'BACKGROUND', 'citation': 'Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.'}, {'pmid': '26275092', 'type': 'BACKGROUND', 'citation': 'Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.'}, {'pmid': '30985536', 'type': 'BACKGROUND', 'citation': 'Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.'}, {'pmid': '21148651', 'type': 'BACKGROUND', 'citation': 'Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.'}, {'pmid': '27792079', 'type': 'BACKGROUND', 'citation': 'Raveendran R, Wong J, Singh M, Wong DT, Chung F. Obesity hypoventilation syndrome, sleep apnea, overlap syndrome: perioperative management to prevent complications. Curr Opin Anaesthesiol. 2017 Feb;30(1):146-155. doi: 10.1097/ACO.0000000000000421.'}, {'pmid': '25311316', 'type': 'BACKGROUND', 'citation': 'Schumann R, Shikora SA, Sigl JC, Kelley SD. Association of metabolic syndrome and surgical factors with pulmonary adverse events, and longitudinal mortality in bariatric surgery. Br J Anaesth. 2015 Jan;114(1):83-90. doi: 10.1093/bja/aeu362. Epub 2014 Oct 13.'}, {'pmid': '29739543', 'type': 'BACKGROUND', 'citation': 'Sultana A, Torres D, Schumann R. Special indications for Opioid Free Anaesthesia and Analgesia, patient and procedure related: Including obesity, sleep apnoea, chronic obstructive pulmonary disease, complex regional pain syndromes, opioid addiction and cancer surgery. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):547-560. doi: 10.1016/j.bpa.2017.11.002. Epub 2017 Nov 16.'}, {'pmid': '29176373', 'type': 'BACKGROUND', 'citation': 'de Raaff CAL, de Vries N, van Wagensveld BA. Obstructive sleep apnea and bariatric surgical guidelines: summary and update. Curr Opin Anaesthesiol. 2018 Feb;31(1):104-109. doi: 10.1097/ACO.0000000000000542.'}, {'pmid': '34565571', 'type': 'BACKGROUND', 'citation': 'Malo-Manso A, Ramirez-Aliaga M, Sepulveda-Haro E, Diaz-Crespo J, Escalona-Belmonte JJ, Guerrero-Orriach JL. Opioid-free anesthesia for open radical cystectomy in morbid obesity. Rev Esp Anestesiol Reanim (Engl Ed). 2021 Sep 23:S0034-9356(21)00134-1. doi: 10.1016/j.redar.2021.03.007. Online ahead of print. English, Spanish.'}, {'pmid': '22020140', 'type': 'BACKGROUND', 'citation': 'Al-Hasani R, Bruchas MR. Molecular mechanisms of opioid receptor-dependent signaling and behavior. Anesthesiology. 2011 Dec;115(6):1363-81. doi: 10.1097/ALN.0b013e318238bba6.'}, {'pmid': '8582088', 'type': 'BACKGROUND', 'citation': 'Kanjhan R. Opioids and pain. Clin Exp Pharmacol Physiol. 1995 Jun-Jul;22(6-7):397-403. doi: 10.1111/j.1440-1681.1995.tb02029.x.'}, {'pmid': '28323774', 'type': 'BACKGROUND', 'citation': 'Weiner SG, Malek SK, Price CN. The Opioid Crisis and Its Consequences. Transplantation. 2017 Apr;101(4):678-681. doi: 10.1097/TP.0000000000001671. No abstract available.'}, {'pmid': '27811241', 'type': 'BACKGROUND', 'citation': 'Burke DS. Forecasting the opioid epidemic. Science. 2016 Nov 4;354(6312):529. doi: 10.1126/science.aal2943. No abstract available.'}, {'pmid': '30802933', 'type': 'BACKGROUND', 'citation': 'Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.'}, {'pmid': '19559105', 'type': 'BACKGROUND', 'citation': 'Chlif M, Keochkerian D, Choquet D, Vaidie A, Ahmaidi S. Effects of obesity on breathing pattern, ventilatory neural drive and mechanics. Respir Physiol Neurobiol. 2009 Sep 30;168(3):198-202. doi: 10.1016/j.resp.2009.06.012. Epub 2009 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'This study compares two different anesthesia techniques in patients with obesity undergoing bariatric surgery: one that includes opioids (OBA), and one that avoids them completely (OFA). The main goal is to determine whether avoiding opioids during surgery leads to lower postoperative morphine requirements and fewer side effects. Researchers reviewed medical records of 70 patients who had bariatric surgery between June 2022 and December 2023 at a hospital in Spain. The study evaluates pain levels, sedation, complications, and total morphine use in the first 48 hours after surgery.', 'detailedDescription': 'This is a single-center, retrospective, observational cohort study conducted at Hospital HM Nou Delfos (Barcelona, Spain). The aim is to compare postoperative opioid requirements and outcomes in patients with morbid obesity undergoing laparoscopic bariatric surgery, according to the intraoperative anesthesia technique used.\n\nTwo anesthetic strategies were evaluated:\n\nOpioid-Free Anesthesia (OFA): Total intravenous anesthesia (TIVA) without opioids, using agents such as propofol, ketamine, dexmedetomidine, lidocaine and magnesium.\n\nOpioid-Based Anesthesia (OBA): TIVA including opioids, following institutional standards.\n\nMedical records of 70 patients (35 in each group) who underwent surgery between June 2022 and December 2023 were analyzed. Key data extracted included demographics, surgical duration, anesthetic drugs used, intraoperative complications, pain scores (VAS at 1, 2, 4, 24, and 48 hours), sedation levels (RAMSAY scale), adverse effects (e.g., nausea, vomiting, ileus, hypotension), and morphine consumption.\n\nThe primary outcome is total morphine use within the first 48 hours postoperatively. Secondary outcomes include pain scores, adverse events, time to awakening, and hospital length of stay. Statistical analysis was performed using descriptive and inferential methods, including regression models adjusted for age, sex, BMI, and comorbidities.\n\nThis study provides real-world evidence on the clinical impact of opioid-free anesthesia in bariatric patients, aiming to improve perioperative safety and enhance postoperative recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (18-65 years) with obesity (BMI ≥ 30 kg/m²) classified as ASA II-III, who underwent laparoscopic bariatric surgery under general anesthesia at HM Nou Delfos between June 2022 and December 2023. Patients were retrospectively assigned to one of two groups based on the anesthetic technique used: opioid-free anesthesia (OFA) or opioid-based anesthesia (OBA).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Age between 18 and 65 years\n\nBody Mass Index (BMI) ≥ 30 kg/m²\n\nASA physical status II or III\n\nUnderwent laparoscopic bariatric surgery under general anesthesia at HM Nou Delfos\n\nSurgery performed between June 1, 2022 and December 31, 2023\n\nExclusion Criteria Pregnancy or breastfeeding\n\nChronic pain patients on high-dose opioids\n\nKnown allergy to any anesthetic drug used in the study\n\nSevere hepatic (e.g., cirrhosis with portal hypertension) or renal insufficiency\n\nUntreated coagulopathy\n\nActive alcohol or drug abuse\n\nUncontrolled or severe psychiatric illness\n\nIntraoperative complications requiring deviation from planned anesthetic technique\n\nPostoperative morphine use exceeding institutional norms for bariatric surgery'}, 'identificationModule': {'nctId': 'NCT07075302', 'acronym': 'OFA VS OBA1', 'briefTitle': 'OFA vs OBA in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital HM Nou Delfos'}, 'officialTitle': 'Comparison of Postoperative Morphine Requirements Between an Opioid-Based and an Opioid-Free Anesthesia Technique in Morbidly Obese Patients Undergoing Bariatric Surgery', 'orgStudyIdInfo': {'id': '25.04.2517-GHM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OFA Group', 'description': 'Patients who received opioid-free total intravenous anesthesia (TIVA) for bariatric surgery, including propofol, lidocaine, ketamine, dexmedetomidine and magnesium, with no intraoperative opioids.'}, {'label': 'OBA Group', 'description': 'Patients who received opioid-based total intravenous anesthesia (TIVA) for bariatric surgery, including propofol and intraoperative opioids such as fentanyl, remifentanil and morphine, following standard practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08023', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital HM Nou Delfos', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Gregory Contreras-Pérez, Anesthesiologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital HM NouDelfos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a retrospective study involving patient health records. Due to ethical and privacy regulations, individual participant data cannot be shared publicly. Access is restricted to the research team as approved by the ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital HM Nou Delfos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'HIPÓLITO LABANDEYRA GONZALEZ', 'investigatorAffiliation': 'Hospital HM Nou Delfos'}}}}