NCT06083948

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
20mo left

Started Dec 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Dec 2023Dec 2027

First Submitted

Initial submission to the registry

September 26, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 19, 2026

Status Verified

December 1, 2025

Enrollment Period

4 years

First QC Date

September 26, 2023

Last Update Submit

March 18, 2026

Conditions

Hypotension

Outcome Measures

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

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

Secondary Outcomes (7)

  • Cerebral metabolic rate of oxygen

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

  • Blood flow through body organs in milliliters per minute as determined by Positron Emission Tomography

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

  • Blood pumped out by the heart per minute (cardiac output)

    Up to one day

  • Ischemic lesions

    Up to 3 days

  • Cerebral tissue oxygen saturation

    Up to one day

  • +2 more secondary outcomes

Study Arms (2)

Noradrenaline

EXPERIMENTAL

Noradrenaline

Drug: Noradrenalin

Phenylephrine

ACTIVE COMPARATOR

Phenylephrine

Drug: Phenylephrine

Interventions

NoradrenalinDRUG

Infusion of noradrenaline during anesthesia and surgery

Also known as: Noradrenaline
Noradrenaline
PhenylephrineDRUG

Infusion of phenylephrine during anesthesia and surgery

Also known as: metaoxedrin
Phenylephrine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40132839DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

NorepinephrinePhenylephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Mads Rasmussen, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasmussen

CONTACT

004529265713mads.rasmussen@vest.rm.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double blinded, clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 16, 2023

Study Start

December 20, 2023

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 19, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

THe trial data may be shared upon request to the Investigator

Shared Documents
STUDY PROTOCOL, CSR, ANALYTIC CODE
Time Frame
Other researchers may request the data after publication of the primary results and for a period of 10 years
Access Criteria
No specific criteria

Locations

DK(1)