Clinical trial · Interventional
Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
NCT06953193CI-TRIAL-00106985recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypotension | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatoduodenectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined General Anesthesia (Thoracic Epidural) | Procedure | — | UNRESOLVED |
| General Anesthesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- General Anesthesia
- description
- Patients will receive general anesthesia for pancreatoduodenectomy. Standardized anesthetic technique will be used with induction and maintenance based on institutional protocols, including intravenous induction agents, inhalational anesthetics, and intraoperative monitoring. No epidural catheter will be placed.
- interventionNames
- Procedure: General Anesthesia
- type
- EXPERIMENTAL
- label
- Combined General Anesthesia (Thoracic Epidural)
- description
- Patients will receive combined general anesthesia (thoracic epidural) for pancreatoduodenectomy. Standardized general anesthesia will be administered as in the general anesthesia group, with the addition of a thoracic epidural catheter placed before induction and maintained intraoperatively with local anesthetics according to institutional protocol.
- interventionNames
- Procedure: Combined General Anesthesia (Thoracic Epidural)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.