Status:
RECRUITING
Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Pancreatic Neoplasms
Hypotension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized clinical trial compares the hemodynamic effects of general anesthesia versus combined general anesthesia (thoracic epidural) in patients undergoing pancreatoduodenectomy. The primary a...
Detailed Description
Pancreatoduodenectomy is a major surgical procedure associated with significant hemodynamic challenges. Thoracic epidural anesthesia provides effective analgesia and may attenuate the surgical stress ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2030
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT06953193
Start Date
April 7 2025
End Date
April 30 2030
Last Update
May 1 2025
Active Locations (1)
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1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico, 14080