METHODS: A total of 64 patients treated with unilateral modified radical mastectomy were randomly divided into an experimental group (esketamine group, Group E) and a control group (Group C), with 32 cases in each one. After anesthesia induction, Group C received 0.2 ml/kg of normal saline intravenously and Group E was administered 0.2 mg/kg intravenous esketamine. The primary outcome was the Patient Health Questionnaire-9 (PHQ-9) scores. The secondary outcomes included the Visual Analogue Scale (VAS) scores for pain, inflammatory markers, perioperative-related indicators, and the incidence of postoperative delirium, nausea and vomiting.
RESULTS: The PHQ-9 score on postoperative day (POD) 1 in Group E declined from the preoperative level, while the score in Group C was higher than before, and the former was far lower than the latter (P = 0.047). There is no statistically significant difference in PHQ-9 scores between Group E and Group C on POD 3, 7, and 30. Moreover, the postoperative leukocyte level of Group E was higher than that of Group C, and the difference was statistically significant (P = 0.030).
CONCLUSIONS: A single subanesthetic dose of esketamine can result in lower postoperative score on subthreshold depressive symptoms compared to the Group C on POD 1, without increasing the occurrence of postoperative adverse reactions.
BACKGROUND: Registration number: Chinese Clinical Trial Registry ChiCTR2200057028. Date of registration: 26/02/2022.
方法:将64例行单侧乳腺癌改良根治术的患者随机分为实验组(艾氯胺酮组,E组)和对照组(C组),每个案例有32个。麻醉诱导后,C组静脉注射生理盐水0.2ml/kg,E组静脉注射艾氯胺酮0.2mg/kg。主要结果是患者健康问卷-9(PHQ-9)评分。次要结果包括疼痛的视觉模拟评分(VAS)评分,炎症标志物,围手术期相关指标,术后谵妄的发生率,恶心和呕吐。
结果:E组术后第1天PHQ-9评分(POD)较术前下降,而C组的得分高于以前,前者远低于后者(P=0.047)。在POD3、7和30上,E组和C组之间的PHQ-9评分没有统计学上的显着差异。此外,术后白细胞水平E组高于C组,差异有统计学意义(P=0.030)。
结论:与C组相比,单剂量亚麻醉药的艾氯胺酮可导致低于POD1组的术后阈下抑郁症状评分,而不增加术后不良反应的发生。
背景:注册号:中国临床试验注册中心ChiCTR2200057028。注册日期:2022年2月26日。