Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms; Hypotension; Pancreatoduodenectomy
• Intervention / Treatment: Procedure: General Anesthesia; Procedure: Combined General Anesthesia (Thoracic Epidural)

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.

• Study Type: Interventional
• Enrollment (Estimated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafael P. Leal Villalpando, MD; Phone Number: 5027 5554 87 09 00; Email: rafael.lealv@incmnsz.mx
• Study Contact Backup: Name: Diana E. Díaz Arizmendi, MD; Phone Number: 5027 5554 87 09 00; Email: diana.diaza@incmnsz.mx

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14080
      • Recruiting
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
      • Contact: Rafael P. Leal Villalpando, MD; Phone Number: 5027 5554 87 09 00; Email: rafael.lealv@incmnsz.mx
      • Contact: Diana E. Díaz Arizmendi, MD; Phone Number: 5027 5554 87 09 00; Email: diana.diaza@incmnsz.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anesthesia; 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.	Procedure: General Anesthesia; 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.
Experimental: Combined General Anesthesia (Thoracic Epidural); 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.	Procedure: Combined General Anesthesia (Thoracic Epidural); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Vasopressor Administered	Type of vasopressor administered intraoperatively, categorized as ephedrine, norepinephrine, adrenaline, dopamine, or dobutamine.	From induction of anesthesia to end of surgery.
Estimated Blood Loss	Total estimated intraoperative blood loss in milliliters.	From start to end of surgery.
Number of Blood Transfusions	Number of units of packed red blood cells transfused intraoperatively.	From start to end of surgery.
ICU Admission Rate	Percentage of patients requiring admission to the intensive care unit after surgery.	Within 24 hours after surgery.
Length of Hospital Stay	Total number of days from the date of surgery to the date of hospital discharge.	Up to 60 days after surgery
Postoperative Complications	Incidence of postoperative complications such as pancreatic fistula, anastomotic leak, surgical site infection, hemorrhage, and acute kidney injury.	Up to 30 days after surgery.
30-Day Mortality	All-cause mortality within 30 days after surgery.	30 days postoperatively.

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): January 7, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pancreatic Surgery; Postoperative Complications; General Anesthesia; Vasopressors; Hemodynamic Changes; Combined Anesthesia
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Pancreatic Neoplasms; Hypotension; Postoperative Complications; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Anesthesia and Analgesia; Plant Preparations; Biological Products; Complex Mixtures; Anesthesia; Tea; Anesthesia, General
• Other Study ID Numbers: ANE-4574-23-24-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No