Ni Tingting, Zhou Xiaoxia, Wu Shuguang, Lv Tao, Hu Yujiao, Gao Qi, Luo Ge, Xie Chen, Zou Jingcheng, Chen Yuexiu, Zhao Linqian, Xiao Jie, Tao Xincheng, Yi Yu, Xu Zhili, Wang Tingting, Zhou Junyu, Yao Yuanyuan, Yan Min
Department of Anesthesiology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Department of Anesthesiology, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yiwu City, China.
JAMA Surg. 2025 May 21. doi: 10.1001/jamasurg.2025.1299.
Postinduction hemodynamic instability is a frequent complication among patients with severe aortic stenosis (AS). Using cipepofol as the anesthesia agent may reduce the incidence and severity of hemodynamic instability.
To assess whether cipepofol outperforms propofol in maintaining postinduction hemodynamic stability in patients with AS.
DESIGN, SETTING, AND PARTICIPANTS: This single-center, randomized clinical trial was conducted from June 29, 2023, to July 8, 2024, at the Second Affiliated Hospital of Zhejiang University School of Medicine in China. Patients with AS scheduled for transcatheter aortic valve replacement (TAVR) were eligible for inclusion.
Participants were randomized 1:1 to receive either cipepofol or propofol as anesthesia induction agents at equipotent doses.
The primary outcome was the area under the curve (AUC) of the mean arterial pressure (MAP) difference from baseline during the initial 15 minutes postinduction.
A total of 124 patients with AS scheduled for TAVR were randomized into either the cipepofol group (n = 62) or the propofol group (n = 62). Of 124 patients randomized, 1 patient from each group was excluded due to ineligibility for the TAVR procedure, and data were analyzed for 122 patients (61 patients per group) based on the intention-to-treat principle. Among 122 total patients, mean (SD) age was 72.2 (5.0) years, and 53 patients (43.4%) were female. The cipepofol group exhibited a significantly smaller median (IQR) AUC (-8505.0 mm Hg · s [-12 402.8 to -5130.0]) compared with the propofol group (-13 189.0 mm Hg · s [-17 006.7 to -7593.3]; P < .001). Moreover, compared with the propofol group, the cipepofol group demonstrated a significantly lower incidence of postinduction hypotension (70.5% vs 88.5%; P = .01) and required a smaller median (IQR) dose of norepinephrine during the first 15 minutes postinduction (6.0 μg [0.0-10.0] vs 10.0 μg [5.0-20.0]; P = .006). Additionally, the 2 groups' bispectral indices were comparable.
In this randomized clinical trial, cipepofol provided superior hemodynamic stability as an induction agent compared to propofol at equipotent doses and similar anesthesia depths for patients with AS. Therefore, cipepofol could serve as an alternative induction agent to propofol for patients at high cardiovascular risk.
ClinicalTrials.gov Identifier: NCT05881291.
诱导后血流动力学不稳定是重度主动脉瓣狭窄(AS)患者常见的并发症。使用西培泊酚作为麻醉剂可能会降低血流动力学不稳定的发生率和严重程度。
评估在维持AS患者诱导后血流动力学稳定性方面,西培泊酚是否优于丙泊酚。
设计、设置和参与者:这项单中心随机临床试验于2023年6月29日至2024年7月8日在中国浙江大学医学院附属第二医院进行。计划进行经导管主动脉瓣置换术(TAVR)的AS患者符合纳入条件。
参与者按1:1随机分组,接受等效剂量的西培泊酚或丙泊酚作为麻醉诱导剂。
主要结局是诱导后最初15分钟内平均动脉压(MAP)与基线差值的曲线下面积(AUC)。
共有124例计划进行TAVR的AS患者被随机分为西培泊酚组(n = 62)或丙泊酚组(n = 62)。在随机分组的124例患者中,每组各有1例患者因不符合TAVR手术条件而被排除,根据意向性分析原则,对122例患者(每组61例)的数据进行了分析。在122例患者中,平均(标准差)年龄为72.2(5.0)岁,53例患者(43.4%)为女性。与丙泊酚组(-13189. mmHg·s [-17006.7至-7593.3])相比,西培泊酚组的中位数(IQR)AUC显著更小(-8505.0 mmHg·s [-12402.8至-5130.0];P < 0.001)。此外,与丙泊酚组相比,西培泊酚组诱导后低血压的发生率显著更低(70.5%对88.5%;P = 0.01),且在诱导后最初15分钟内所需去甲肾上腺素的中位数(IQR)剂量更小(6.0 μg [0.0 - 10.0]对10.0 μg [5.0 - 20.0];P = 0.006)。此外,两组的脑电双频指数具有可比性。
在这项随机临床试验中,对于AS患者,在等效剂量和相似麻醉深度下,西培泊酚作为诱导剂比丙泊酚提供了更好的血流动力学稳定性。因此,西培泊酚可作为心血管高风险患者替代丙泊酚的诱导剂。
ClinicalTrials.gov标识符:NCT05881291。