氯胺酮用于术后避免抑郁症状：K-PASS 可行性随机试验

BJA open Pub Date : 2023-12-15 DOI:10.1016/j.bjao.2023.100245

Bradley A. Fritz , Bethany R. Tellor Pennington , Catherine Dalton , Christine Horan , Ben J.A. Palanca , Julie A. Schweiger , Logan Griffin , Wilberforce Tumwesige , Jon T. Willie , Nuri B. Farber

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摘要

背景曾患有抑郁症的手术患者经常会出现术后抑郁症状。本研究的目的是确定一项安慰剂对照试验的可行性，测试持续输注氯胺酮对术后抑郁症状的影响。方法这项单中心、三重盲法、安慰剂对照随机临床试验纳入了计划接受住院手术的成年抑郁症患者。手术后，患者被随机分配接受氯胺酮（10 分钟内 0.5 毫克/公斤-1，然后 0.3 毫克/公斤-1 小时-1，持续 3 小时）或等量的生理盐水。抑郁症状采用蒙哥马利-阿斯伯格抑郁量表进行测量。注射后第 1 天，参与者猜测自己接受了哪种干预。可行性终点包括接受随机治疗的患者比例、完成研究输液的随机患者比例以及完成预定抑郁评估的患者比例。结果共有 32 名患者被分配了治疗方案，其中包括在方案变更后接受治疗的 31/101 名患者（31%，每周 1.5 名患者）。有 30/32 名患者（94%）不间断地完成了输液治疗。在每组中，有 7/16 名参与者正确猜出了他们接受的干预措施。在 170/192 个预定时间点完成了抑郁评估（89%）。从基线到输液后第4天（预先指定的相关时间点），两组患者的抑郁症状中位数均有所下降，氯胺酮与安慰剂相比，差异为-1.00点（95%置信区间-3.23至1.73）。结论在保持盲法的前提下，患者招募、用药和临床结果测量似乎非常可行。临床试验注册号：NCT05233566。

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Ketamine for postoperative avoidance of depressive symptoms: the K-PASS feasibility randomised trial

Background

Surgical patients with previous depression frequently experience postoperative depressive symptoms. This study's objective was to determine the feasibility of a placebo-controlled trial testing the impact of a sustained ketamine infusion on postoperative depressive symptoms.

Methods

This single-centre, triple-blind, placebo-controlled randomised clinical trial included adult patients with depression scheduled for inpatient surgery. After surgery, patients were randomly allocated to receive ketamine (0.5 mg kg⁻¹ over 10 min followed by 0.3 mg kg⁻¹ h⁻¹ for 3 h) or an equal volume of normal saline. Depressive symptoms were measured using the Montgomery–Asberg Depression Rating Scale. On post-infusion day 1, participants guessed which intervention they received. Feasibility endpoints included the fraction of patients approached who were randomised, the fraction of randomised patients who completed the study infusion, and the fraction of scheduled depression assessments that were completed.

Results

In total, 32 patients were allocated a treatment, including 31/101 patients approached after a protocol change (31%, 1.5 patients per week). The study infusion was completed without interruption in 30/32 patients (94%). In each group, 7/16 participants correctly guessed which intervention they received. Depression assessments were completed at 170/192 scheduled time points (89%). Between baseline and post-infusion day 4 (pre-specified time point of interest), median depressive symptoms decreased in both groups, with difference-in-differences of −1.00 point (95% confidence interval −3.23 to 1.73) with ketamine compared with placebo. However, the between-group difference did not persist at other time points.

Conclusions

Patient recruitment, medication administration, and clinical outcome measurement appear to be highly feasible, with blinding maintained. A fully powered trial may be warranted.