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

Phase 1

• Conditions: Hypotension during anesthesia for brain tumor surgery; MedDRA version: 21.0Level: LLTClassification code 10056679Term: Intraoperative hypotensionSystem Organ Class: 100000004863; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2021-006168-26-DK
• Lead Sponsor: Aarhus University Hospital, Department of Anesthesia(Bedøvelse og operation)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-10
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 (?=<br>posttreatment value-pretreatment value).;Timepoint(s) of evaluation of this end point: Within 6 months after inclusion of the last subject

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The between-group differences in cardiac output, muscle blood flow,<br>myocardial blood flow, cerebral metabolic rate of oxygen, oxygen<br>extraction fraction, cerebral tissue oxygen saturation , ratio's between<br>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