Pancreatic NeoplasmsNCT06953193
Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
A study testing General Anesthesia and Combined General Anesthesia (Thoracic Epidural) in people with Pancreatic Neoplasms and Hypotension, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Hypotension, Pancreatoduodenectomy
- What is being tested?
- General Anesthesia and Combined General Anesthesia (Thoracic Epidural)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteMexico
- Study dates
- 7 Apr 2025to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico City, 14080
Rafael P. Leal Villalpando, MD, 5554 87 09 00 ext. 5027, rafael.lealv@incmnsz.mx
Diana E. Díaz Arizmendi, MD, 5554 87 09 00 ext. 5027, diana.diaza@incmnsz.mx
About this study
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.
Read the 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.
- Conditions
- Pancreatic Neoplasms, Hypotension, Pancreatoduodenectomy
- Being tested
- General Anesthesia, Combined General Anesthesia (Thoracic Epidural)
- Keywords
- Pancreatic Surgery, General Anesthesia, Hemodynamic Changes, Vasopressors, Postoperative Complications, Combined Anesthesia
- Medical subject headings
- Pancreatic Neoplasms, Hypotension, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaProcedure or surgery
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.
Combined General Anesthesia (Thoracic Epidural)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Active comparator | 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. Receives: Procedure: General Anesthesia |
| Combined General Anesthesia (Thoracic Epidural) | Experimental | 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. Receives: Procedure: Combined General Anesthesia (Thoracic Epidural) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From induction of anesthesia to end of surgery (intraoperative period).
Secondary outcomes (7)
Type of Vasopressor Administered
Type of vasopressor administered intraoperatively, categorized as ephedrine, norepinephrine, adrenaline, dopamine, or dobutamine.
Measured: From induction of anesthesia to end of surgery.
Estimated Blood Loss
Total estimated intraoperative blood loss in milliliters.
Measured: From start to end of surgery.
Number of Blood Transfusions
Number of units of packed red blood cells transfused intraoperatively.
Measured: From start to end of surgery.
ICU Admission Rate
Percentage of patients requiring admission to the intensive care unit after surgery.
Measured: Within 24 hours after surgery.
Length of Hospital Stay
Total number of days from the date of surgery to the date of hospital discharge.
Measured: 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.
Measured: Up to 30 days after surgery.
30-Day Mortality
All-cause mortality within 30 days after surgery.
Measured: 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start7 Apr 2025
- Primary completion7 Jan 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Paulino Leal Villalpando, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953193
- Sponsor's protocol ID
- ANE-4574-23-24-1
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Hypotension in Pancreatoduodenectomy: A Randomized Trial of General Versus Combined Anesthesia
- ClinicalTrials.gov ID
- NCT06953193
- Acronym / sponsor ID
- ANE-4574-23-24-1
- Conditions
- Pancreatic Neoplasms, Hypotension, Pancreatoduodenectomy
- Keywords
- Pancreatic Surgery, General Anesthesia, Hemodynamic Changes, Vasopressors, Postoperative Complications, Combined Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 7 Jan 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Active comparator | Procedure: General AnesthesiaPatients 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) | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General AnesthesiaPatients 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. | Procedure or surgery | General Anesthesia |
| 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. | Procedure or surgery | Combined General Anesthesia (Thoracic Epidural) |
Primary outcome
Incidence of Intraoperative Hypotension
Time frame: From induction of anesthesia to end of surgery (intraoperative period).
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.
7 secondary outcomes
Type of Vasopressor Administered
Time frame: From induction of anesthesia to end of surgery.
Estimated Blood Loss
Time frame: From start to end of surgery.
Number of Blood Transfusions
Time frame: From start to end of surgery.
ICU Admission Rate
Time frame: Within 24 hours after surgery.
Length of Hospital Stay
Time frame: Up to 60 days after surgery
Postoperative Complications
Time frame: Up to 30 days after surgery.
30-Day Mortality
Time frame: 30 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia and Combined General Anesthesia (Thoracic Epidural) in people with Pancreatic Neoplasms and Hypotension, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafael P. Leal Villalpando, MD (5554 87 09 00 ext. 5027, rafael.lealv@incmnsz.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Intraoperative Hypotension (time frame: From induction of anesthesia to end of surgery (intraoperative period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.