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Study on the Effects of Phenylephrine and Noradrenaline on Blood Pressure and Brain Circulation in Patients with Low Blood Pressure During Brain Tumor Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two medications, Phenylephrine and Noradrenaline Tartrate, on patients experiencing low blood pressure during anesthesia. These medications are used to help manage blood pressure levels during surgery. The study aims to understand how these medications affect blood flow and oxygen levels in the brain, as well as their impact on the heart and muscles, in patients undergoing surgery to remove brain tumors.

The trial involves patients who are scheduled for a specific type of brain surgery called a craniotomy, which is performed to remove tumors from the brain. During the study, participants will receive either Phenylephrine or Noradrenaline Tartrate through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The goal is to observe any differences in how these medications affect the body's circulation and the brain's oxygen supply.

The study will monitor changes in blood flow and oxygenation before and after treatment with these medications. By comparing the effects of Phenylephrine and Noradrenaline Tartrate, researchers hope to gain insights into which medication might be more beneficial for maintaining stable blood pressure and ensuring adequate blood flow to the brain during surgery. This research is part of an international effort to improve outcomes for patients undergoing brain tumor surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed for individuals aged 18 to 75 years who are scheduled for elective craniotomy for supratentorial tumors with a minimum size of 3 cm.

  2. Step 2

    Preparation for surgery

    Before surgery, the patient is prepared for the procedure. This includes standard pre-operative assessments and ensuring the patient is ready for anesthesia.

  3. Step 3

    Administration of medication

    During the surgery, if low blood pressure occurs, one of two medications, phenylephrine or noradrenaline tartrate, is administered intravenously. These medications are used to manage blood pressure and improve blood flow to the brain and other organs.

  4. Step 4

    Monitoring during surgery

    Throughout the surgery, the patient's systemic hemodynamics, which refers to the blood flow and circulation in the body, are closely monitored. The focus is on understanding how the medication affects cerebral circulation and oxygenation.

  5. Step 5

    Post-treatment evaluation

    After the administration of the medication, the primary endpoint is assessed. This involves measuring the difference in cerebral blood flow (CBF) before and after treatment to evaluate the impact of the medication.

  6. Step 6

    Follow-up

    Following the surgery and initial recovery, further evaluations may be conducted to assess the long-term effects of the treatment on brain and organ perfusion.

Who can join the trial?

6 criteria

  • Participants must be between the ages of 18 and 75 years old.
  • Participants should be scheduled for a planned surgery called a craniotomy, which is a procedure to remove a brain tumor.
  • The brain tumor must be located in the supratentorial region, which is the upper part of the brain.
  • The tumor must be at least 3 centimeters in size, which is about the size of a small lime, measured in any direction.
  • Both men and women can participate in the study.
  • Participants should not belong to a vulnerable population, meaning they should be able to give informed consent and understand the study.

Who cannot join the trial?

1 criterion

  • Patients who have experienced low blood pressure during anesthesia cannot participate. Anesthesia is the medicine used to make you sleep during surgery, and low blood pressure means your blood pressure drops too low, which can be risky.
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Investigated drugs

  • Phenylephrine

    is a medication used to increase blood pressure by narrowing blood vessels. In this clinical trial, it is being studied to see how it affects blood flow and oxygen levels in the brain of patients undergoing brain tumor surgery. Researchers want to understand if it can help improve brain outcomes during the operation.

  • Noradrenaline

    , also known as norepinephrine, is another medication used to raise blood pressure by tightening blood vessels. This trial is examining its effects on brain circulation and oxygenation in patients having brain tumor surgery. The goal is to see how it influences blood flow to the brain and other organs like the heart and muscles during the procedure.

What is already known about the treatment

  • Phenylephrine

    Phenylephrine is administered intravenously and is commonly used to manage low blood pressure during anesthesia. It is well-documented in medical literature as a vasopressor, which means it helps constrict blood vessels to increase blood pressure. The main therapeutic indication for phenylephrine is to stabilize blood pressure in patients undergoing surgery, particularly those with brain tumors. At the molecular level, phenylephrine works by stimulating alpha-1 adrenergic receptors, leading to vasoconstriction. It is classified pharmacologically as a sympathomimetic agent.

  • Norepinephrine

    Norepinephrine is also administered intravenously and is used to treat low blood pressure during anesthesia. It is widely recognized in medical literature as a potent vasopressor. The primary therapeutic use of norepinephrine is to maintain adequate blood pressure in surgical patients, especially those undergoing brain tumor removal. Its mechanism of action involves stimulating both alpha and beta adrenergic receptors, resulting in increased vascular tone and cardiac output. Norepinephrine is classified as a catecholamine and sympathomimetic agent.

Investigated diseases

Low Blood Pressure During Anesthesia – This condition occurs when blood pressure drops to abnormally low levels during the administration of anesthesia. It can lead to inadequate blood flow to vital organs, including the brain, heart, and muscles. Patients may experience dizziness, fainting, or a feeling of weakness. The condition is often temporary and related to the effects of anesthesia on the body's circulatory system. It is important to monitor and manage blood pressure during surgical procedures to ensure proper organ perfusion. Understanding the impact of different vasopressor agents on blood pressure and organ perfusion is crucial in managing this condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515400-40-00Estimated enrolment32 patientsSponsorRegion Midtjylland

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