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Recruiting NCT06953193

Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia

Trial Parameters

Condition Pancreatic Neoplasms
Sponsor Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Type INTERVENTIONAL
Phase N/A
Enrollment 206
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-07
Completion 2030-01-07
Interventions
General AnesthesiaCombined General Anesthesia (Thoracic Epidural)

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Signed written informed consent. * Patients scheduled for elective pancreatoduodenectomy at National Institute of Medical Sciences and Nutrition Salvador Zubirán. * No contraindications for neuroaxial anesthesia (epidural catheter placement), including: * Generalized or localized infection at the puncture site. * Thrombocytopenia. * Coagulation disorders. * Intracranial hypertension. * Patient refusal. Exclusion Criteria: * Age under 18 years. * Pregnancy. * Inability to randomize the case due to specific circumstances (such as contraindications to epidural use), resulting in non-eligibility based on participation criteria.

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