Comparing noradrenaline and phenylephrine effects on blood flow during brain surgery
Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia in Neurosurgical Patients
This study is testing whether noradrenaline or phenylephrine is better at keeping blood flow and oxygen levels stable during brain surgery for people with brain tumors.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06083948 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal vasopressor for maintaining organ blood flow and tissue oxygen delivery during neurosurgery in patients with brain tumors. It involves a randomized, double-blinded design where participants will receive either noradrenaline or phenylephrine infusion. The study will utilize PET scans to measure blood flow and oxygen consumption in the brain and other vital organs before surgery. A total of 32 patients aged 18 to 75 with diagnosed brain tumors will be enrolled for this investigation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with diagnosed supratentorial brain tumors scheduled for elective craniotomy.
Not a fit: Patients with severe ASA physical status (IV-VI), those with allergies to the study medications, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could identify the most effective vasopressor to enhance organ perfusion and oxygenation during neurosurgery, potentially improving patient outcomes.
How similar studies have performed: Previous studies have explored vasopressor effects in surgical settings, but this specific comparison of noradrenaline and phenylephrine in neurosurgery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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). 2. Scheduled for elective supratentorial craniotomy. 3. Patients aged between 18 and 75 years. 4. American Society of Anesthesiologists status 1-3 Exclusion Criteria: 1. History of allergy or intolerance to one of the study medications. 2. Active treatment with monoamine oxidase inhibitors. 3. An American Society of Anesthesiologists (ASA)physical status IV-VI. 4. Pregnancy or breastfeeding. 5. Inability to provide written informed consent -
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Mads Rasmussen, MD, PhD — Aarhus University Hospital
- Study coordinator: Rasmussen
- Email: mads.rasmussen@vest.rm.dk
- Phone: 004529265713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.