Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia

ConditionHypotension
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Noradrenalin

    Drug

    Infusion of noradrenaline during anesthesia and surgery

  • Phenylephrine

    Drug

    Infusion of phenylephrine during anesthesia and surgery

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: NoradrenalineExperimental treatment 1 intervention
Group B: PhenylephrineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cerebral blood flow

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 outcomes

1

Cerebral metabolic rate of oxygen

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)
2

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

Time frame
Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
3

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

Time frame
Up to one day
4

Ischemic lesions

Ischemic lesions possibly associated with vasopressor use as detected on the postoperative MRI examination

Time frame
Up to 3 days

Other outcomes

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