Zhou Yang, Ma Bo, Sun Wanchen, Wang Juan, Fu Yuxuan, Wang Anxin, Wang Gang, Han Ruquan
Department of Anaesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, People's Republic of China.
Department of Statistics, China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, People's Republic of China.
BMJ Open. 2022 Apr 26;12(4):e056713. doi: 10.1136/bmjopen-2021-056713.
Depressive symptoms are common for patients undergoing major surgery and may worsen their mental health and lead to poor clinical outcomes. It is essential to seek a safe rapid-acting treatment for relieving moderate-to-severe depressive symptoms in patients undergoing major surgery.
This study is a randomised, placebo-controlled and double-blinded trial aiming to determine the effect of esketamine on moderate-to-severe depressive symptoms in patients undergoing major surgery. Five hundred and sixty-four participants, aged 18-65 years old, undergoing major surgery will be randomly allocated into the esketamine and placebo groups at a 1:1 ratio. Esketamine or placebo will be given intravenously at the same speed on suturing the incision by anaesthesiologists in charge who are blinded to the randomisation. In the esketamine group, the total dosage of esketamine will be 0.2 mg/kg body weight. To estimate the efficacy and safety endpoints, blinded evaluation by trained researchers will be completed at 3 days, 5 days, 1 month, 3 months and 6 months after surgery. The primary outcome is the remission rate at the third postoperative day. The secondary outcomes include depression-related scores, severe pain events and safety-related endpoints such as psychotic symptoms, manic symptoms and dissociative symptoms.
This study was approved by the Institutional Review Board of Beijing Tiantan Hospital, Capital Medical University, Beijing, China on 30 October 2020 (KY-2020-058-02). This trial is designed to explore whether the administration of esketamine could improve the mental health of patients with depressive symptoms undergoing major surgery. The conclusions of this study will be published in peer-reviewed journals.
NCT04425473.
抑郁症状在接受大手术的患者中很常见，可能会恶化他们的心理健康并导致不良的临床结果。为接受大手术的患者寻求一种安全、速效的治疗方法以缓解中重度抑郁症状至关重要。
本研究是一项随机、安慰剂对照、双盲试验，旨在确定艾氯胺酮对接受大手术患者中重度抑郁症状的影响。564名年龄在18至65岁之间、接受大手术的参与者将按1:1的比例随机分配到艾氯胺酮组和安慰剂组。由对随机分组不知情的负责麻醉师在缝合切口时以相同速度静脉注射艾氯胺酮或安慰剂。在艾氯胺酮组中，艾氯胺酮的总剂量将为0.2mg/kg体重。为评估疗效和安全性终点，由经过培训的研究人员在术后3天、5天、1个月、3个月和6个月进行盲法评估。主要结局是术后第三天的缓解率。次要结局包括抑郁相关评分、严重疼痛事件以及与安全相关的终点，如精神病性症状、躁狂症状和解离症状。
本研究于2020年10月30日获得中国北京首都医科大学附属北京天坛医院机构审查委员会批准（KY-2020-058-02）。本试验旨在探讨给予艾氯胺酮是否能改善有抑郁症状的大手术患者的心理健康。本研究的结论将发表在同行评审期刊上。
NCT04425473。
