Actively Recruiting
Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
Led by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Updated on 2026-04-01
206
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial investigates the effects of general anesthesia compared to combined general anesthesia with thoracic epidural in patients undergoing pancreatoduodenectomy, a complex surgical procedure. The study aims to assess the incidence of low blood pressure during surgery and related complications, as well as secondary factors like medication needs, blood transfusions, postoperative complications, ICU admissions, hospital stay length, and mortality. Participants will be randomly assigned to one of two groups. One group will receive standard general anesthesia using intravenous and inhaled medications without an epidural catheter. The other group will receive combined anesthesia with a thoracic epidural catheter placed before surgery, delivering local anesthetics alongside general anesthesia. Both groups will follow institutional protocols for anesthesia induction and maintenance. During the surgery and recovery period, an independent observer will monitor blood pressure and other vital signs without knowing the group assignments. Researchers will track vasopressor use, blood loss, transfusions, postoperative complications such as infections or organ injury, ICU admissions, hospital stay duration, and mortality up to 30 days after surgery. The study includes an interim safety review after the first 66 patients. Participants' involvement will last through the surgery and postoperative follow-up up to 60 days.
CONDITIONS
Brief Title
Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Scheduled for elective pancreatoduodenectomy at National Institute of Medical Sciences and Nutrition Salvador Zubirán.
- No contraindications for neuroaxial anesthesia, such as no infection at puncture site, no thrombocytopenia, no coagulation disorders, no intracranial hypertension, and no patient refusal.
You will not qualify if you...
- Age under 18 years.
- Pregnancy.
- Inability to randomize due to contraindications to epidural use or other specific circumstances.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo pancreatoduodenectomy surgery with either general anesthesia or combined general anesthesia (thoracic epidural). Intraoperative monitoring of blood pressure and other hemodynamic parameters is performed during surgery.
1 surgical visit (in-person)
Duration - Up to 60 days after surgery
Participants are monitored for postoperative complications, ICU admission, length of hospital stay, and mortality up to 30 to 60 days after surgery.
Approximately 3 to 4 visits (in-person)
Trial Site Locations
Total: 1 location
1
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
Research Team
R
Rafael P. Leal Villalpando, MD
D
Diana E. Díaz Arizmendi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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