Effect of esketamine on postoperative depression in women with breast cancer and preoperative depressive symptoms: The EASE randomized trial.
Qingfeng Wei, Mengmeng Li, Qiuling Du, Huiwen Zhang, Yongjie Liang, Cen Cheng, Bin Mei, Xiaowei Yang, Yinguang Fan, Jiajia Zhu, Jingjie Zhang, Yongqiang Yu, Qiying Shen, Xuesheng Liu, Daniel I Sessler
Journal of clinical anesthesia April 1, 2025 DOI: 10.1016/j.jclinane.2025.111821 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 108 |
| Population | Women 18-65 years old scheduled for elective breast cancer surgery with preoperative depressive symptoms |
| Intervention | Esketamine |
| Dose | 0.25 mg/kg |
| Duration | Intraoperative administration over 40 minutes, with outcomes assessed up to 5 postoperative days |
| Topics | Depression Esketamine |
| Keywords | Anti-depressant Breast cancer Surgery Breast carcinoma Mood disorder treatment Esketamine ketamine derivative Rapid-acting antidepressant Surgical oncology cancer |
| Citations | 10 |
| Key findings | Intraoperative esketamine did not significantly increase the rate of 50% depression score reduction at three days postoperatively, but it significantly lowered short-term depression scores without increasing complications. |
Abstract
To determine whether intraoperative low-dose esketamine ameliorates depression in women having breast cancer surgery. A prospective single-center double blind randomized placebo-controlled trial. Perioperative period, operating room, post anesthesia care unit and hospital ward. 108 women 18-65 years old who were scheduled for elective breast cancer surgery. All had preoperative depressive symptoms as defined by Montgomery-Åsberg depression scores ≥12 (range, 0-60; higher scores indicate more severe depression). Eligible participants were randomized to esketamine 0.25 mg/kg or saline placebo. Blinded trial drugs were given intravenously over the initial 40 min of anesthesia. Our primary outcome was the fraction of patients who had at least a 50 % reduction in the Montgomery-Åsberg depression score within 3 postoperative days. Secondary outcomes included the fraction of patients with depression remission defined as Montgomery-Åsberg scores ≤10, the numeric value of the Montgomery-Åsberg depression scores, postoperative severe pain, and anxiety as determined by the Generalized Anxiety Disorder 7-item score. Adverse events were monitored for 72 postoperative hours. 54 women each were randomized to esketamine and saline, and 104 were available for our intent-to-treat analysis. The mean age was 50 years. Esketamine non-significantly doubled the fraction of patients who had a 50 % reduction in their depressions scores: 27 % vs 13 %, odds ratio 2.4, [95 % CI 0.9 to 6.6], P = 0.087. Montgomery-Åsberg depression scores were nearly a factor-of-two and significantly lower (better) on postoperative days 1 to 5 in patients given esketamine. Montgomery-Åsberg scores decreased significantly more from baseline in patients randomized to esketamine: mean difference - 2.5 [95 % CI -4.5 to -0.6], P = 0.010. Esketamine treatment had no significant effect on other secondary outcomes or on adverse events. Intraoperative administration of 0.25 mg/kg esketamine did not significantly improve the fraction of depressed women having breast cancer patients who had a 50 % reduction in their depression scores at 3 days postoperatively. However, the observed factor-of-two treatment effect was clinically meaningful and esketamine significantly reduced short-term postoperative depression scores without provoking complications. Robust trials are warranted. Registration Trial registry:http://www.chictr.org.cn/; Identifier: ChiCTR2300071062.
Comparable studies
Other randomized controlled trials on esketamine for depression, most cited first.