Effect of esketamine on postoperative depression in women with breast cancer and preoperative depressive symptoms: The EASE randomized trial.

Abstract

<h4>Study objective</h4>To determine whether intraoperative low-dose esketamine ameliorates depression in women having breast cancer surgery.<h4>Design</h4>A prospective single-center double blind randomized placebo-controlled trial.<h4>Setting</h4>Perioperative period, operating room, post anesthesia care unit and hospital ward.<h4>Patients</h4>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).<h4>Interventions</h4>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.<h4>Measurements</h4>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.<h4>Main results</h4>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.<h4>Conclusions</h4>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.

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