Clinical trial · Interventional
Vasopressor Effects in Anesthetized Patients
Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients With Cerebral Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients with Cerebral Tumors Sponsor-investigator: Klaus Ulrik Koch M.D. Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark Objective: To investigate whether phenylephrine and ephedrine causes different alterations in microcirculation and oxygenation, as measured with MRI and PET, in anesthetized patients with brain tumors. 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 Method: Double blinded controlled randomized clinical trial. Either phenylephrine or ephedrine are infused intravenously under general anesthesia. MRI is performed in 20 patients before and after infusion. PET/CT is performed in 20 patients before and after infusion. BIS and NIRS monitoring will be used in either scanner. After scanning patients are transported to the operating theatre and the craniotomy is performed. After removal of the bone flap subdural ICP is measured and recorded. MRI to analyze 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. During each PET/CT scan session oxygen saturation and hemoglobin concentration is measured. Data from the proposed studies will add substantial new knowledge to the investigators current understanding of the effects of vasopressors on cerebral circulation. This information will aid the neuroanesthesiologist, neurointensivist and the neurosurgeon in the choice of the optimal method to manage cerebral perfusion pressure during craniotomy for brain tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ephedrine | Drug | — | UNRESOLVED |
| Phenylephrine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Ephedrine
- interventionNames
- Drug: Ephedrine
- type
- ACTIVE_COMPARATOR
- label
- Phenylephrine
- interventionNames
- Drug: Phenylephrine
Primary outcomes (1)
- measure
- Capillary Transit Time Heterogeneity
- timeFrame
- 4 Years
Secondary outcomes (1)
- measure
- Cerebral Metabolic Rate of Oxygen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for supine-positioned elective craniotomy for supratentorial malignant and non-malignant brain tumors 3 cm or larger (measured as the largest diameter in any plane on MR images) * ASA (American Society of Anesthesiologist) status 1-3 (27) * Written informed consent from participating patients Exclusion Criteria: * Age younger than 18 yrs. or older than 75 yrs. * Pregnancy or nursing (negative pregnancy blood test) * History of allergic reactions to phenylephrine or ephedrine * eGFR \< 60ml/min/1.73m2
References
Publications (27)
- BACKGROUNDRasmussen M, Bundgaard H, Cold GE. Craniotomy for supratentorial brain tumors: risk factors for brain swelling after opening the dura mater. J Neurosurg. 2004 Oct;101(4):621-6. doi: 10.3171/jns.2004.101.4.0621. PMID 15481716
- BACKGROUNDRasmussen M, Juul N, Christensen SM, Jonsdottir KY, Gyldensted C, Vestergaard-Poulsen P, Cold GE, Ostergaard L. Cerebral blood flow, blood volume, and mean transit time responses to propofol and indomethacin in peritumor and contralateral brain regions: perioperative perfusion-weighted magnetic resonance imaging in patients with brain tumors. Anesthesiology. 2010 Jan;112(1):50-6. doi: 10.1097/ALN.0b013e3181c38bd3. PMID 19952725
- BACKGROUNDRasmussen M, Ostergaard L, Juul N, Gyldensted C, Poulsen PV, Cold GE. Do indomethacin and propofol cause cerebral ischemic damage? Diffusion-weighted magnetic resonance imaging in patients undergoing craniotomy for brain tumors. Anesthesiology. 2004 Oct;101(4):872-8. doi: 10.1097/00000542-200410000-00011. PMID 15448519
- BACKGROUNDDubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17. PMID 19534818
- BACKGROUNDBrain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. XIV. Hyperventilation. J Neurotrauma. 2007;24 Suppl 1:S87-90. doi: 10.1089/neu.2007.9982. No abstract available. PMID 17511553
- BACKGROUNDBoerma EC, Ince C. The role of vasoactive agents in the resuscitation of microvascular perfusion and tissue oxygenation in critically ill patients. Intensive Care Med. 2010 Dec;36(12):2004-18. doi: 10.1007/s00134-010-1970-x. Epub 2010 Sep 2.