Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
Recruiting · NCT06953193 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
View the official record on ClinicalTrials.gov →Interventions studied
Combined General Anesthesia (Thoracic Epidural)General Anesthesia
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán - Mexico City, Mexico City, Mexico