Vasopressor Effects in Anesthetized Patients
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|ClinicalTrials.gov Identifier: NCT02713087|
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : October 26, 2018
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
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Drug: Ephedrine Drug: Phenylephrine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients With Cerebral Tumors|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
|Active Comparator: Ephedrine||
Infusion of Ephedrine 2mg/ml until MAP above 60 mmHg or until MAP has raised 20%
|Active Comparator: Phenylephrine||
Infusion of Phenylephrine 0,1mg/ml until MAP above 60 mmHg or until MAP has raised 20%
- Capillary Transit Time Heterogeneity [ Time Frame: 4 Years ]
- Cerebral Metabolic Rate of Oxygen [ Time Frame: 4 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713087
|Aarhus University Hospital|
|Aarhus, Jylland, Denmark, 8000|
|Study Director:||Leif Oestergaard, Professor||University of Aarhus|