NCT06953193 Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
| NCT ID | NCT06953193 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Condition | Pancreatic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 206 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2030-01-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 206 participants in total. It began in 2025-04-07 with a primary completion date of 2030-01-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06953193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06953193 currently recruiting?
Yes, NCT06953193 is actively recruiting participants. Contact the research team at rafael.lealv@incmnsz.mx for enrollment information.
Where is the NCT06953193 trial being conducted?
This trial is being conducted at Mexico City, Mexico.
Who is sponsoring the NCT06953193 clinical trial?
NCT06953193 is sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. The trial plans to enroll 206 participants.