Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-01-07 @ 9:13 PM
Study NCT ID:
NCT06953193
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Study Overview
Official Title:
Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Pancreatoduodenectomy is a major surgical procedure associated with significant hemodynamic challenges. Thoracic epidural anesthesia provides effective analgesia and may attenuate the surgical stress response, its intraoperative use has been associated with increased risk of hypotension and higher vasopressor requirements.
This randomized clinical trial aims to evaluate intraoperative hemodynamic changes in patients undergoing elective pancreatoduodenectomy managed with either general anesthesia or combined general anesthesia (thoracic epidural). A total of 206 patients will be enrolled at the "National Institute of Medical Sciences and Nutrition Salvador Zubirán". Patients will be randomized into two groups: one receiving general anesthesia and the other receiving combined general anesthesia (thoracic epidural).
Randomization will be performed using the REDCap platform with a simple 1:1 allocation ratio. Each patient's group assignment will be generated automatically by REDCap at the time of enrollment to ensure allocation concealment.
An independent observer, blinded to the anesthetic technique, will monitor and record episodes of hypotension throughout the perioperative period. The principal investigator will be blinded to group assignment.
Secondary outcomes include intraoperative vasopressor use, estimated blood loss, transfusion requirements, postoperative complications (such as pancreatic fistula, anastomotic leak, hemorrhage, surgical site infection, and acute kidney injury), admission to the intensive care unit, length of stay in the ICU and hospital, and mortality.
A planned interim analysis will be conducted after the enrollment of the first 66 patients to assess the safety and feasibility of the study protocol. Based on this analysis, modifications to improve patient safety may be recommended by the research team or ethics committee.
This study will help determine the optimal anesthetic strategy to minimize hemodynamic instability and postoperative morbidity in patients undergoing pancreatoduodenectomy.
This randomized clinical trial aims to evaluate intraoperative hemodynamic changes in patients undergoing elective pancreatoduodenectomy managed with either general anesthesia or combined general anesthesia (thoracic epidural). A total of 206 patients will be enrolled at the "National Institute of Medical Sciences and Nutrition Salvador Zubirán". Patients will be randomized into two groups: one receiving general anesthesia and the other receiving combined general anesthesia (thoracic epidural).
Randomization will be performed using the REDCap platform with a simple 1:1 allocation ratio. Each patient's group assignment will be generated automatically by REDCap at the time of enrollment to ensure allocation concealment.
An independent observer, blinded to the anesthetic technique, will monitor and record episodes of hypotension throughout the perioperative period. The principal investigator will be blinded to group assignment.
Secondary outcomes include intraoperative vasopressor use, estimated blood loss, transfusion requirements, postoperative complications (such as pancreatic fistula, anastomotic leak, hemorrhage, surgical site infection, and acute kidney injury), admission to the intensive care unit, length of stay in the ICU and hospital, and mortality.
A planned interim analysis will be conducted after the enrollment of the first 66 patients to assess the safety and feasibility of the study protocol. Based on this analysis, modifications to improve patient safety may be recommended by the research team or ethics committee.
This study will help determine the optimal anesthetic strategy to minimize hemodynamic instability and postoperative morbidity in patients undergoing pancreatoduodenectomy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: