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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
RECRUITING
Mexico City
Contact Information
Primary
Rafael P. Leal Villalpando, MD
rafael.lealv@incmnsz.mx
5554 87 09 00
Backup
Diana E. Díaz Arizmendi, MD
diana.diaza@incmnsz.mx
7225338022
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 206
Treatments
Active_comparator: General Anesthesia
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.
Experimental: Combined General Anesthesia (Thoracic Epidural)
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.
Sponsors
Leads: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

This content was sourced from clinicaltrials.gov