Influence of vasopressors on brain oxygenation and microcirculation in anesthetized patients with cerebral tumors

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001359-60-DK

Enrollment

Registered

2015-04-23

Start date

2015-06-16

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain oxygenation and microcirculation under administration of Efedrin and Metaoxedrin in patients with cerebral tumor. MedDRA version: 19.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864

Interventions

Trade Name: Efedrin Metaoxedrin Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: Efedrin CAS Number: 50-98-6 Current Sponsor code: EPHEDRINE HYDROC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients scheduled for supine-positioned elective craniotomy for supratentorial brain tumors. ASA(American Society of Anaesthesiologist status) 1-3. Written informed consent from participating patients Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Age younger than 18 yrs. or older than 75 yrs. Pregnancy or nursing (negative pregnancy test). History of allergic reactions to phenylephedrine or ephedrine. eGFR < 45ml/min/1.73m2

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether phenylephrine and ephedrine causes different alterations in microcirculation and oxygenation, as measured with magnetic resonance imaging (MRI) and positron emission tomography (PET), in anesthetized patients with brain tumors.;Secondary Objective: Using MRI and PET, the study will assess whether there is a difference in deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine. ;Primary end point(s): Conventional diffusion- and perfusion-weigthed MRI to analyze color-coded CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after ephedrine and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and phenylephrine and calculation of OEF.;Timepoint(s) of evaluation of this end point: The above mentioned parameters are calculated on basis of MRI and PET/CT imaging, which is obtained before surgery. Time in either MR or PET/CT will be 1 hour.	—

Measure

Time frame

Main Objective: To investigate whether phenylephrine and ephedrine causes different alterations in microcirculation and oxygenation, as measured with magnetic resonance imaging (MRI) and positron emission tomography (PET), in anesthetized patients with brain tumors.;Secondary Objective: Using MRI and PET, the study will assess whether there is a difference in deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine. ;Primary end point(s): Conventional diffusion- and perfusion-weigthed MRI to analyze color-coded CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after ephedrine and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and phenylephrine and calculation of OEF.;Timepoint(s) of evaluation of this end point: The above mentioned parameters are calculated on basis of MRI and PET/CT imaging, which is obtained before surgery. Time in either MR or PET/CT will be 1 hour.

—

Secondary

Measure	Time frame
Secondary end point(s): During each PET/CT scan session oxygen saturation and hemoglobin concentration is measured. Subdural ICP measurements during surgery. ;Timepoint(s) of evaluation of this end point: The above mentioned parameters are estimated at various time points during a 3 hour period	—

Countries

Denmark

Contacts

Public ContactNeuroanesthesia trial info/KK

Aarhus University Hospital

klaukoch@rm.dk4578463333

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026