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.
Signed written informed consent.
Patients scheduled for elective pancreatoduodenectomy at National Institute of Medical Sciences and Nutrition Salvador Zubirán.
Generalized or localized infection at the puncture site.
Thrombocytopenia.
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.
Parallel
General Anesthesia
Procedure/SurgeryPatients will undergo balanced general anesthesia for pancreatoduodenectomy. Induction will include: fentanyl 4 mcg/kg, lidocaine 1 mg/kg, propofol 1.5 mg/kg, and rocuronium 0.6 mg/kg. Anesthesia maintenance will be achieved with sevoflurane (variable concentration as per anesthesiologist discretion) and continuous fentanyl infusion according to the attending anesthesiologist's judgment. No epidural catheter will be placed.
Combined General Anesthesia (Thoracic Epidural)
Procedure/SurgeryPatients will undergo combined general anesthesia (thoracic epidural) for pancreatoduodenectomy. Induction will include: fentanyl 4 mcg/kg, lidocaine 1 mg/kg, propofol 1.5 mg/kg, and rocuronium 0.6 mg/kg. A thoracic epidural catheter will be placed at the best palpable intervertebral space between T6-T9 by the attending anesthesiologist. Anesthesia 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.
Incidence of Intraoperative Hypotension
Defined as the occurrence of any mean arterial pressure (MAP) \<65 mmHg during the intraoperative period, measured continuously with an invasive arterial line or intermittently with a non-invasive blood pressure monitor, as available.
Type of Vasopressor Administered
Type of vasopressor administered intraoperatively, categorized as ephedrine, norepinephrine, adrenaline, dopamine, or dobutamine.
Estimated Blood Loss
Total estimated intraoperative blood loss in milliliters.
Number of Blood Transfusions
Number of units of packed red blood cells transfused intraoperatively.
ICU Admission Rate
Percentage of patients requiring admission to the intensive care unit after surgery.
Click on the lead sponsor to view all of their trials.
