Comparison of two blood pressure stimulating drugs(phenylephrine vs. noradrenaline)on bloodflow and oxygen supply to the brain and body tissues during anesthesia in anesthetized brain tumor patients

IMpact of Phenylephrine vs. norAdrenaline on systemic hemodynamics and Cerebral Tissue circulation and oxygenation in anesthetized brain tumor patients (IMPACT) - IMPACT

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006168-26-DK

Enrollment

Registered

2022-01-10

Start date

2022-05-12

Completion date

Unknown

Last updated

2022-05-23

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

Conditions

Hypotension during anesthesia for brain tumor surgery MedDRA version: 21.0 Level: LLT Classification code 10056679 Term: Intraoperative hypotension System Organ Class: 100000004863

Interventions

Trade Name: Fenylefrin Pharmaceutical Form: Solution for infusion INN or Proposed INN: Phenylephrine Other descriptive name: PHENYLEPHRINE HYDROCHLORIDE Concentration unit: µg/ml microgram(s)/millilit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects aged 18-75 yr. scheduled for elective craniotomy for supratentorial tumors with a minimum size of 3 cm (measured as the largest diameter in any plane) are included 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Exclusion criteria are history of allergy or intolerance to one of the study medications, an American Society of Anesthesiologists (ASA) physical status IV to VI, pregnancy (positive pregnancy urine test) or breastfeeding and inability to give written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: In the attempt to improve brain outcomes, we initiate this interdisciplinary and international collaborative project to understand the impact of two commonly used vasopressor agents (phenylephrine vs. noradrenaline) on cerebral circulation and oxygenation in patients undergoing brain tumor resection. We also aim to understand the impact of vasopressor-induced changes in systemic hemodynamics on regional perfusion in organs including the brain, heart and muscle. ;Secondary Objective: The project shall further assess whether the vasopressor effects on CBF during anesthesia are dependent on cardiac performance.;Primary end point(s): The primary endpoint is the between-group difference in ?CBF (?= posttreatment value-pretreatment value).;Timepoint(s) of evaluation of this end point: Within 6 months after inclusion of the last subject	—

Measure

Time frame

Main Objective: In the attempt to improve brain outcomes, we initiate this interdisciplinary and international collaborative project to understand the impact of two commonly used vasopressor agents (phenylephrine vs. noradrenaline) on cerebral circulation and oxygenation in patients undergoing brain tumor resection. We also aim to understand the impact of vasopressor-induced changes in systemic hemodynamics on regional perfusion in organs including the brain, heart and muscle. ;Secondary Objective: The project shall further assess whether the vasopressor effects on CBF during anesthesia are dependent on cardiac performance.;Primary end point(s): The primary endpoint is the between-group difference in ?CBF (?= posttreatment value-pretreatment value).;Timepoint(s) of evaluation of this end point: Within 6 months after inclusion of the last subject

—

Secondary

Measure	Time frame
Secondary end point(s): The between-group differences in cardiac output, muscle blood flow, myocardial blood flow, cerebral metabolic rate of oxygen, oxygen extraction fraction, cerebral tissue oxygen saturation , ratio's between organ's blood flow and the between-organ differences in blood flow;Timepoint(s) of evaluation of this end point: Within 6 months after inclusion of the last subject	—

Countries

Denmark

Contacts

Public ContactDepartment of Anesthesia

Aarhus University Hospital

4529265713

Outcome results

None listed

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