Li Muhan, Yin Xueke, Liang Chuanyu, Tao Chenyang, Yan Qixiao, Zeng Min, Li Shu, Sessler Daniel I, Wang Rong, Zhao Lei, Peng Yuming
Department of Anaesthesiology, Beijing Tiantan Hospital Capital Medical University, Beijing, Beijing, China.
Department of Anaesthesiology, Xuanwu Hospital Capital Medical University, Beijing, Beijing, China.
BMJ Open. 2025 Jun 19;15(6):e094156. doi: 10.1136/bmjopen-2024-094156.
Impaired cerebral autoregulation is associated with postoperative ischaemic brain injury and often occurs in patients with carotid artery stenosis. Adequate cerebral perfusion should therefore be maintained during carotid endarterectomies. Whether guiding intraoperative blood pressure to the Cerebral Oximetry Index (a measure of cerebral perfusion adequacy) reduces postoperative cerebral ischaemia remains unclear.
We plan a dual-centre randomised blinded trial. A total of 560 patients having elective carotid endarterectomy will be randomly assigned to guided versus routine haemodynamic management. In patients randomised to guided management, mean arterial pressure will be titrated to maintain a normal cerebral oximetry index. In the routine care group, mean arterial pressure will be targeted to within 20% of individual preoperative baseline values. The primary outcome will be the incidence of new ischaemic brain injury within 3 days after surgery assessed by brain imaging, with or without clinical symptoms. Secondary outcomes include the incidence of postoperative delirium, cognitive function and pain severity.
The study protocol (V.1.2, 1 January 2025) has been approved by the Medical Ethics Committee of Beijing Tiantan Hospital, Capital Medicine University (KY2024-049-03) and Xuanwu Hospital, Capital Medical University (LYS2025-023-001). The findings of the study will be disseminated in a peer-reviewed journal and at a scientific conference.
NCT06406842.
脑自动调节功能受损与术后缺血性脑损伤相关，且常见于颈动脉狭窄患者。因此，在颈动脉内膜切除术中应维持充足的脑灌注。术中将血压调整至脑氧饱和度指数（衡量脑灌注充足程度的指标）是否能降低术后脑缺血尚不清楚。
我们计划开展一项双中心随机盲法试验。总共560例行择期颈动脉内膜切除术的患者将被随机分配至指导性血流动力学管理组或常规血流动力学管理组。在随机分配至指导性管理组的患者中，平均动脉压将进行滴定调整以维持正常的脑氧饱和度指数。在常规护理组中，平均动脉压的目标是维持在个体术前基线值的20%以内。主要结局将是术后3天内通过脑成像评估的新发缺血性脑损伤的发生率，无论有无临床症状。次要结局包括术后谵妄的发生率、认知功能和疼痛严重程度。
本研究方案（V.1.2，2025年1月1日）已获得首都医科大学附属北京天坛医院医学伦理委员会（KY2024 - 049 - 03）和首都医科大学宣武医院（LYS2025 - 023 - 001）的批准。本研究结果将在同行评审期刊和科学会议上发表。
NCT06406842。
