Faisal Mohamad Niwar, Koch Klaus Ulrik, Aanerud Joel, Meier Kaare, Mikkelsen Irene Klærke, Espelund Ulrick S, Eriksen Christian Fenger, Juul Niels, Alstrup Karen Baden, Jespersen Bo, Fries Lene Marie, Tankisi Alp, Dyrskog Stig, Cortnum Søren Ole Stigaard, Sindby Ann Katrine, Borghammer Per, Tolbod Lars Poulsen, Meng LingZhong, Korshoej Anders Rosendal, Rasmussen Mads
Department of Anesthesiology, Section of Neuroanesthesia, Aarhus University Hospital, Aarhus, Denmark
Department of Anesthesiology and Intensive Care, Goedstrup Regional Hospital, Goedstrup, Denmark.
BMJ Open. 2025 Mar 25;15(3):e095172. doi: 10.1136/bmjopen-2024-095172.
Vasopressor support is often preferred as an efficient and convenient way to raise the blood pressure during surgery and intensive care therapy. However, the optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined. This study aims to assess the impact of norepinephrine versus phenylephrine on cerebral and non-cerebral organ perfusion and oxygenation during anaesthesia in neurosurgical patients with brain tumours. The study also explores the impact of the vasopressor agents on the distribution of cardiac output between various organs.
This is an investigator-initiated, double-blinded, randomised clinical trial including 32 patients scheduled for supratentorial brain tumour surgery. The patients are randomised to receive a phenylephrine or norepinephrine infusion during preoperative positron emission tomography (PET) examinations and the following neurosurgical procedure. PET measurements of blood flow and oxygen metabolism in the brain and other organs are performed on the awake subject during anaesthesia, following a 10% and 20% gradual increase in blood pressure from the baseline value. The primary endpoint is the between-group difference in cerebral blood flow. Secondary endpoints include detection of ischaemic brain lesions possibly associated with vasopressor treatment, changes in cerebral oxygen metabolism, non-cerebral organ blood flow and oxygen metabolism, cardiac output, regional cerebral oxygen saturation, autoregulation and distribution of cardiac output between organs.
This study was approved by the Danish National Medical Ethics Committee (20 May 2022; 2203674). Results will be disseminated via peer-reviewed publication and presentation at international conferences.
EudraCT no: 2021-006168-26.
gov: NCT06083948.
血管升压药支持通常被视为在手术和重症监护治疗期间升高血压的一种有效且便捷的方法。然而，在手术期间确保器官血流和组织氧输送的最佳血管升压药仍未确定。本研究旨在评估去甲肾上腺素与去氧肾上腺素对患有脑肿瘤的神经外科手术患者麻醉期间脑和非脑器官灌注及氧合的影响。该研究还探讨了血管升压药对各器官心输出量分布的影响。
这是一项由研究者发起的双盲随机临床试验，纳入32例计划行幕上脑肿瘤手术的患者。患者在术前正电子发射断层扫描（PET）检查及随后的神经外科手术过程中被随机分配接受去氧肾上腺素或去甲肾上腺素输注。在麻醉期间，对清醒受试者进行PET测量脑和其他器官的血流及氧代谢，血压从基线值逐步升高10%和20%。主要终点是脑血流的组间差异。次要终点包括检测可能与血管升压药治疗相关的缺血性脑病变、脑氧代谢变化、非脑器官血流和氧代谢、心输出量、局部脑氧饱和度、自动调节以及心输出量在各器官之间的分布。
本研究已获得丹麦国家医学伦理委员会批准（2022年5月20日；2203674）。研究结果将通过同行评审发表以及在国际会议上展示的方式进行传播。
欧洲临床试验注册号：2021 - 006168 - 26。
NCT06083948。
