Comparing general anesthesia to combined anesthesia during pancreatic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the hemodynamic effects of general anesthesia versus combined general anesthesia (thoracic epidural) in patients undergoing pancreatoduodenectomy. It aims to assess the incidence of intraoperative hypotension and related adverse events, while also measuring secondary outcomes such as vasopressor requirements, transfusion needs, and postoperative complications. A total of 206 patients will be randomized into two groups, with an independent observer monitoring hypotension throughout the perioperative period to ensure unbiased results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  Mexico City, Mexico City, Mexico Recruiting

Study contacts

• Study coordinator: Rafael P. Leal Villalpando, MD
• Email: rafael.lealv@incmnsz.mx
• Phone: 5554 87 09 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.