Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia (IMPACT)
Primary Purpose
Hypotension
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Noradrenalin
Phenylephrine
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of supratentorial malignant or non-malignant brain tumors. Preferably 3 cm or larger( measured as the largest diameter in any plane on MRI). Scheduled for elective supratentorial craniotomy. Patients aged between 18 and 75 years. American Society of Anesthesiologists status 1-3 Exclusion Criteria: History of allergy or intolerance to one of the study medications. Active treatment with monoamine oxidase inhibitors. An American Society of Anesthesiologists (ASA)physical status IV-VI. Pregnancy or breastfeeding. Inability to provide written informed consent -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Noradrenaline
Phenylephrine
Arm Description
Noradrenaline
Phenylephrine
Outcomes
Primary Outcome Measures
Cerebral blood flow
Blood flow measured in milliliters per minute through selected regions of the brain as determined by Positron Emission Tomography
Secondary Outcome Measures
Cerebral metabolic rate of oxygen
Cerebral oxygen consumption in selected regions of the brain as determined by Positron Emission Tomography
Blood flow through body organs in milliliters per minute as determined by Positron Emission Tomography
Blood flow in various body organs supplied by the systemic circulation
Blood pumped out by the heart per minute (cardiac output)
Cardiac output as determined by Positron Emission Tomography and/or by beat-to-beat determination by analysis of the arterial blood pressure waveform
Ischemic lesions
Ischemic lesions possibly associated with vasopressor use as detected on the postoperative MRI examination
Cerebral tissue oxygen saturation
Cerebral tissue oxygen saturation as measured with near infrared spectroscopy (NIRS)
Bispectral Index (BIS)
Depth of anesthesia as measured by BIS
Organ metabolic rate of Oxygen
Oxygen consumption in various organs as measured by Positron Emission Tomography
Full Information
NCT ID
NCT06083948
First Posted
September 26, 2023
Last Updated
October 23, 2023
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT06083948
Brief Title
Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia
Acronym
IMPACT
Official Title
Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia in Neurosurgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined. This study aim to compare the effects of noradrenaline vs. phenylephrine infusion on blood flow and oxygen delivery to the brain and various other organs in anesthetized neurosurgical patients.
Detailed Description
The brain and other blood flow sensitive organs are vulnerable to hypotension during neurosurgery. As a countermeasure, vasopressor agents are often administered to increase blood pressure. The ultimate goal of the vasopressor is to secure perfusion of vital organs and fulfill their metabolic demand. However, the optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined.The aim of this study is to compare the effects of noradrenaline vs. phenylephrine infusion on blood flow and oxygen consumption in the brain and various other organs in anesthetized neurosurgical patients.
The project constitutes a clinical randomized study involving 40 patients diagnosed with brain tumors. The study is conducted on the same day as their scheduled brain tumor surgery. The study is designed as a randomized, double-blinded clinical trial, with two distinct groups: Group 1 receives phenylephrine, while Group 2 receives noradrenaline.
PET exams of blood flow and oxygen consumption in brain and organs are performed using a PET scanner with a wide field of view. The wide field of view allow for simultaneous multiorgan blood flow and oxygen consumption measurements.
Four positron emission tomography (PET) examinations are performed prior to the surgical procedure. The first PET examination (PET 1) is performed on the awake patient. The patient is then anesthetized, and the PET exam is repeated (PET 2). Vasopressor infusion is initiated and titrated to increase mean arterial blood pressure(MABP) above 60 mmHg, or by 10% relative to baseline(baseline MABP is measured prior to PET 2). The PET exam is repeated (PET 3). MABP is further increased to above 70 mmHg or by 20 % relative to the baseline level. The PET exam is repeated (PET 4). The anesthetized patient is then transported to the surgical theatre and surgery is initiated. During the surgical procedure, MABP is maintained between 70-80 mmHg according to institutional guidelines. The vasopressor infusion is terminated after completion of the surgery.. Invasive blood pressure, cardiac output (CO),depth of anesthesia (bispectral index) and brain tissue oxygen saturation(near infrared spectroscopy) are continuously measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blinded, clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Noradrenaline
Arm Type
Experimental
Arm Description
Noradrenaline
Arm Title
Phenylephrine
Arm Type
Active Comparator
Arm Description
Phenylephrine
Intervention Type
Drug
Intervention Name(s)
Noradrenalin
Other Intervention Name(s)
Noradrenaline
Intervention Description
Infusion of noradrenaline during anesthesia and surgery
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
metaoxedrin
Intervention Description
Infusion of phenylephrine during anesthesia and surgery
Primary Outcome Measure Information:
Title
Cerebral blood flow
Description
Blood flow measured in milliliters per minute through selected regions of the brain as determined by Positron Emission Tomography
Time Frame
Up to 3 hours (measured on the day of surgery prior to the surgical procedure)
Secondary Outcome Measure Information:
Title
Cerebral metabolic rate of oxygen
Description
Cerebral oxygen consumption in selected regions of the brain as determined by Positron Emission Tomography
Time Frame
Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
Title
Blood flow through body organs in milliliters per minute as determined by Positron Emission Tomography
Description
Blood flow in various body organs supplied by the systemic circulation
Time Frame
Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
Title
Blood pumped out by the heart per minute (cardiac output)
Description
Cardiac output as determined by Positron Emission Tomography and/or by beat-to-beat determination by analysis of the arterial blood pressure waveform
Time Frame
Up to one day
Title
Ischemic lesions
Description
Ischemic lesions possibly associated with vasopressor use as detected on the postoperative MRI examination
Time Frame
Up to 3 days
Title
Cerebral tissue oxygen saturation
Description
Cerebral tissue oxygen saturation as measured with near infrared spectroscopy (NIRS)
Time Frame
Up to one day
Title
Bispectral Index (BIS)
Description
Depth of anesthesia as measured by BIS
Time Frame
Up to one day
Title
Organ metabolic rate of Oxygen
Description
Oxygen consumption in various organs as measured by Positron Emission Tomography
Time Frame
Up to 3 hours (measured on the day of surgery prior to the surgical procedure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of supratentorial malignant or non-malignant brain tumors. Preferably 3 cm or larger( measured as the largest diameter in any plane on MRI).
Scheduled for elective supratentorial craniotomy.
Patients aged between 18 and 75 years.
American Society of Anesthesiologists status 1-3
Exclusion Criteria:
History of allergy or intolerance to one of the study medications.
Active treatment with monoamine oxidase inhibitors.
An American Society of Anesthesiologists (ASA)physical status IV-VI.
Pregnancy or breastfeeding.
Inability to provide written informed consent -
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
THe trial data may be shared upon request to the Investigator
IPD Sharing Time Frame
Other researchers may request the data after publication of the primary results and for a period of 10 years
IPD Sharing Access Criteria
No specific criteria
Learn more about this trial
Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia
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