Intraoperative Hypotension In Pancreatoduodenectomy: A Randomized Trial Of General Versus Combined Anesthesia

Study Overview

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.

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.

Pancreatic Neoplasms
Hypotension
Pancreatoduodenectomy

PROCEDURE: General Anesthesia
PROCEDURE: Combined General Anesthesia (Thoracic Epidural)

ANE-4574-23-24-1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-23
First Submitted that Met QC Criteria 2025-04-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-01
First Posted (ACTUAL) 2025-05-01	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

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 intra	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 co 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 t
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 induc	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 t

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 intra

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 co

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 t

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 induc

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 t

Primary Outcome Measures	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	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.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Rafael P. Leal Villalpando, MD

Phone Number: 5554 87 09 00

Email: rafael.lealv@incmnsz.mx

Study Contact Backup

Name: Diana E. Díaz Arizmendi, MD

Phone Number: 7225338022

Email: diana.diaza@incmnsz.mx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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