RecruitingNot ApplicableNCT06953193

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

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Enrollment

206 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Neoplasms Pancreatoduodenectomy Hypotension

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

Min Age: 18 Years

Inclusion Criteria8

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 Criteria3

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.

Interventions

PROCEDUREGeneral Anesthesia

Patients 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.

PROCEDURECombined General Anesthesia (Thoracic Epidural)

Patients 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.