Clinical trial NCT06953193: Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
Official title: Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Neoplasms
Hypotension
Pancreatoduodenectomy
Keywords: Pancreatic Surgery
General Anesthesia
Hemodynamic Changes
Vasopressors
Postoperative Complications
Combined Anesthesia
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of Intraoperative Hypotension
timeFrame: From induction of anesthesia to end of surgery (intraoperative period).
Secondary outcomes:
measure: Type of Vasopressor Administered
timeFrame: From induction of anesthesia to end of surgery.
measure: Estimated Blood Loss
timeFrame: From start to end of surgery.
measure: Number of Blood Transfusions
timeFrame: From start to end of surgery.
measure: ICU Admission Rate
timeFrame: Within 24 hours after surgery.
measure: Length of Hospital Stay
timeFrame: Up to 60 days after surgery
measure: Postoperative Complications
timeFrame: Up to 30 days after surgery.
measure: 30-Day Mortality
timeFrame: 30 days postoperatively.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
References: