[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589344":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":55,"collaborators":25,"id":59,"slug":25,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"General Anesthesia","ACTIVE_COMPARATOR","Patients will receive general anesthesia for pancreatoduodenectomy. Standardized anesthetic technique will be used with induction and maintenance based on institutional protocols, including intravenous induction agents, inhalational anesthetics, and intraoperative monitoring. No epidural catheter will be placed.",[13],"Procedure: General Anesthesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Combined General Anesthesia (Thoracic Epidural)","EXPERIMENTAL","Patients will receive combined general anesthesia (thoracic epidural) for pancreatoduodenectomy. Standardized general anesthesia will be administered as in the general anesthesia group, with the addition of a thoracic epidural catheter placed before induction and maintained intraoperatively with local anesthetics according to institutional protocol.",[19],"Procedure: Combined General Anesthesia (Thoracic Epidural)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Patients will undergo balanced general anesthesia for pancreatoduodenectomy. Induction will include: fentanyl 4 mcg\u002Fkg, lidocaine 1 mg\u002Fkg, propofol 1.5 mg\u002Fkg, and rocuronium 0.6 mg\u002Fkg.\n\nAnesthesia maintenance will be achieved with sevoflurane (variable concentration as per anesthesiologist discretion) and continuous fentanyl infusion according to the attending anesthesiologist's judgment.\n\nNo epidural catheter will be placed.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients will undergo combined general anesthesia (thoracic epidural) for pancreatoduodenectomy.\n\nInduction will include: fentanyl 4 mcg\u002Fkg, lidocaine 1 mg\u002Fkg, propofol 1.5 mg\u002Fkg, and rocuronium 0.6 mg\u002Fkg.\n\nA thoracic epidural catheter will be placed at the best palpable intervertebral space between T6-T9 by the attending anesthesiologist.\n\nAnesthesia maintenance will include sevoflurane (variable concentration), fentanyl infusion at the anesthesiologist's discretion, and continuous infusion of 0.25% bupivacaine via the epidural catheter throughout the surgery.",[15],[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Rafael P. Leal Villalpando, MD","CONTACT","5554 87 09 00","5027","rafael.lealv@incmnsz.mx",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},"Diana E. Díaz Arizmendi, MD","diana.diaza@incmnsz.mx",[40],{"facility":41,"status":42,"city":43,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán","RECRUITING","Mexico City","14080","Mexico",{"type":47,"coordinates":48},"Point",[49,50],-99.12766,19.42847,{"lat":50,"lon":49},[53,54],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Rafael Paulino Leal Villalpando","Chief of the Department of Anesthesiology","100589344",false,"NCT06953193","Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia","Inclusion Criteria:\n\n* Signed written informed consent.\n* Patients scheduled for elective pancreatoduodenectomy at National Institute of Medical Sciences and Nutrition Salvador Zubirán.\n* No contraindications for neuroaxial anesthesia (epidural catheter placement), including:\n\n  * Generalized or localized infection at the puncture site.\n  * Thrombocytopenia.\n  * Coagulation disorders.\n  * Intracranial hypertension.\n  * Patient refusal.\n\nExclusion Criteria:\n\n* Age under 18 years.\n* Pregnancy.\n* Inability to randomize the case due to specific circumstances (such as contraindications to epidural use), resulting in non-eligibility based on participation criteria.","ALL","18 Years",{"count":67,"type":68},206,"ESTIMATED","INTERVENTIONAL",[71],"NA","This randomized clinical trial compares the hemodynamic effects of general anesthesia versus combined general anesthesia (thoracic epidural) in patients undergoing pancreatoduodenectomy. The primary aim is to assess the incidence of intraoperative hypotension and related adverse events. Secondary outcomes includes vasopressor requirements, transfusion needs, postoperative complications, intensive care unit admission, hospital length of stay, and mortality.",[74,75,76],"Pancreatic Neoplasms","Hypotension","Pancreatoduodenectomy",[78,9,79,80,81,82],"Pancreatic Surgery","Hemodynamic Changes","Vasopressors","Postoperative Complications","Combined Anesthesia","2026-03-27",{"date":85,"type":86},"2026-04-01","ACTUAL",{"date":88,"type":86},"2025-04-07",{"date":90,"type":68},"2030-04-30",{"name":5,"class":6},1]