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

Plain Language Summary

Simplified for easier understanding

This study compares two types of anesthesia — general anesthesia alone versus general anesthesia combined with an epidural (regional nerve block) — to see which approach better prevents low blood pressure during a major pancreatic surgery called pancreatoduodenectomy (Whipple procedure). Low blood pressure during surgery can cause serious complications, and researchers want to identify the safer approach. **You may be eligible if...** - You are 18 or older - You are scheduled for an elective Whipple surgery at a specific medical center in Mexico - You have no contraindications to receiving an epidural **You may NOT be eligible if...** - You are under 18 or pregnant - You have a blood clotting disorder, very low platelet count, an infection at the epidural site, or high pressure in the brain (which would make an epidural unsafe) - You refused to have an epidural placed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.