Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
1 other identifier
interventional
206
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2025
CompletedStudy Start
First participant enrolled
April 7, 2025
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 7, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
April 1, 2026
April 1, 2025
4.8 years
April 7, 2025
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Intraoperative Hypotension
Defined as the occurrence of any mean arterial pressure (MAP) \<65 mmHg during the intraoperative period, measured continuously with an invasive arterial line or intermittently with a non-invasive blood pressure monitor, as available.
From induction of anesthesia to end of surgery (intraoperative period).
Secondary Outcomes (7)
Type of Vasopressor Administered
From induction of anesthesia to end of surgery.
Estimated Blood Loss
From start to end of surgery.
Number of Blood Transfusions
From start to end of surgery.
ICU Admission Rate
Within 24 hours after surgery.
Length of Hospital Stay
Up to 60 days after surgery
- +2 more secondary outcomes
Study Arms (2)
General Anesthesia
ACTIVE COMPARATORPatients 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.
Combined General Anesthesia (Thoracic Epidural)
EXPERIMENTALPatients 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.
Interventions
Patients will undergo balanced general anesthesia for pancreatoduodenectomy. Induction will include: fentanyl 4 mcg/kg, lidocaine 1 mg/kg, propofol 1.5 mg/kg, and rocuronium 0.6 mg/kg. Anesthesia maintenance will be achieved with sevoflurane (variable concentration as per anesthesiologist discretion) and continuous fentanyl infusion according to the attending anesthesiologist's judgment. No epidural catheter will be placed.
Patients will undergo combined general anesthesia (thoracic epidural) for pancreatoduodenectomy. Induction will include: fentanyl 4 mcg/kg, lidocaine 1 mg/kg, propofol 1.5 mg/kg, and rocuronium 0.6 mg/kg. A thoracic epidural catheter will be placed at the best palpable intervertebral space between T6-T9 by the attending anesthesiologist. Anesthesia maintenance will include sevoflurane (variable concentration), fentanyl infusion at the anesthesiologist's discretion, and continuous infusion of 0.25% bupivacaine via the epidural catheter throughout the surgery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, 14080, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Both the investigator and the outcomes assessor will be blinded to the group assignment. Care providers will not be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of the Department of Anesthesiology
Study Record Dates
First Submitted
April 7, 2025
First Posted
May 1, 2025
Study Start
April 7, 2025
Primary Completion (Estimated)
January 7, 2030
Study Completion (Estimated)
April 30, 2030
Last Updated
April 1, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share