Comparing general anesthesia to combined anesthesia during pancreatic surgery
Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
NA · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · NCT06953193
This study is testing whether using general anesthesia alone or combined with an epidural is better for people having pancreatic surgery, focusing on how it affects blood pressure and other related issues during and after the operation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (other) |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT06953193 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for elective pancreatoduodenectomy without contraindications for neuroaxial anesthesia.
Not a fit: Patients under 18 years, pregnant women, or those with contraindications to epidural anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of intraoperative hypotension during pancreatic surgeries, enhancing patient safety and outcomes.
How similar studies have performed: Other studies have shown varying results with similar approaches, but this specific comparison of anesthesia techniques in pancreatoduodenectomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City, Mexico City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Neoplasms, Hypotension, Pancreatoduodenectomy, Pancreatic Surgery, General Anesthesia, Hemodynamic Changes, Vasopressors, Postoperative Complications