Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia
NCT ID: NCT06083948
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
32 participants
INTERVENTIONAL
2023-12-20
2025-12-31
Brief Summary
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Detailed Description
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The project constitutes a clinical randomized study involving 32\* 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(including myocardium, kidney, liver, spinal cord, organs supplied by the splanchnic circulation, muscle tissue and other 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 and 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.An MRI examination is performed 24 hours after surgery to detect any ischemic lesions possibly associated with the vasopressor infusion.
\* The initial sample size of 40 patients was reduced to 32 patients in april 2024 (after inclusion of 4 patients). The change in sample size is due to unexpected limited scanner availability and unexpected difficuties with patient recruitment. These factors will be associated with a longer period of patient inclusion and consequently longer time before study completion which we find unacceptable.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Noradrenaline
Noradrenaline
Noradrenalin
Infusion of noradrenaline during anesthesia and surgery
Phenylephrine
Phenylephrine
Phenylephrine
Infusion of phenylephrine during anesthesia and surgery
Interventions
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Noradrenalin
Infusion of noradrenaline during anesthesia and surgery
Phenylephrine
Infusion of phenylephrine during anesthesia and surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Scheduled for elective supratentorial craniotomy.
3. Patients aged between 18 and 75 years.
4. American Society of Anesthesiologists status 1-3
Exclusion Criteria
2. Active treatment with monoamine oxidase inhibitors.
3. An American Society of Anesthesiologists (ASA)physical status IV-VI.
4. Pregnancy or breastfeeding.
5. Inability to provide written informed consent -
18 Years
75 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Mads Rasmussen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Mads Rasmussen, MD, PhD
Role: primary
References
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Faisal Mohamad N, Koch KU, Aanerud J, Meier K, Mikkelsen IK, Espelund US, Eriksen CF, Juul N, Alstrup KB, Jespersen B, Fries LM, Tankisi A, Dyrskog S, Cortnum SOS, Sindby AK, Borghammer P, Tolbod LP, Meng L, Korshoej AR, Rasmussen M. Impact of norepinephrine versus phenylephrine on brain circulation, organ blood flow and tissue oxygenation in anaesthetised patients with brain tumours: study protocol for a randomised controlled trial. BMJ Open. 2025 Mar 25;15(3):e095172. doi: 10.1136/bmjopen-2024-095172.
Other Identifiers
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IMPACT study
Identifier Type: -
Identifier Source: org_study_id