Effect of Intraoperative Esketamine Infusion on Postoperative Sleep Disturbance After Gynecological Laparoscopy: A Randomized Clinical Trial.
Effect of Intraoperative Esketamine Infusion on Postoperative Sleep Disturbance After Gynecological Laparoscopy: A Randomized Clinical Trial.
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术中输注艾氯胺酮对妇科腹腔镜术后睡眠障碍的影响：一项随机临床试验
DOI：
10.1001/jamanetworkopen.2022.44514
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发表时间：
2022-12-01
影响因子：
13.8
通讯作者：
Yang, Jian-Jun
中科院分区：
文献类型：
--
作者：
Qiu, Di;Wang, Xing-Ming;Yang, Jin-Jin;Chen, Sai;Yue, Cai-Bao;Hashimoto, Kenji;Yang, Jian-Jun
本随机临床试验探讨术中输注艾氯胺酮对妇科腹腔镜手术后睡眠障碍发生率的影响。静脉输注艾氯胺酮是否能预防妇科腹腔镜手术后第1天和第3天的睡眠障碍？在这项随机临床试验中，183名在中国接受妇科腹腔镜手术的女性患者，艾氯胺酮显著降低了PSD的发病率。本试验结果表明，术中输注艾氯胺酮对妇科腹腔镜手术患者PSD的发生率有预防作用；需要进一步的研究来证实这些发现。术后睡眠障碍（PSD）在术后患者中很常见。探讨术中输注艾氯胺酮对妇科腹腔镜手术患者PSD发生率的影响。这项单中心、双盲、安慰剂对照的随机临床试验于2021年8月至2022年4月在中国郑州大学第一附属医院进行。参与者包括接受妇科腹腔镜手术的年龄在18至65岁之间，美国麻醉医师协会身体状态分类为I至III （I表示健康患者，II表示患有轻度全身性疾病的患者，III表示患有严重全身性疾病的患者）的患者。患者被随机分配到艾氯胺酮组或对照组。使用每协议原则分析数据。艾氯胺酮组患者术中持续输注艾氯胺酮，0.3 mg/kg/h。对照组患者给予等量生理盐水。主要观察指标是术后第1天和第3天PSD的发生率。术后睡眠障碍的定义为数值评定量表得分为6分或更高，或雅典失眠症量表得分为6分或更高。次要结局包括术后焦虑和抑郁评分（采用医院焦虑和抑郁量表）、术后疼痛（采用视觉模拟量表）、术后氢吗啡酮用量以及与PSD相关的危险因素。183例女性患者随机分为对照组（n = 91，中位年龄45[35-49]岁）和艾氯胺酮组（n = 92，中位年龄43[32-49]岁）。艾氯胺酮组在POD 1上PSD的发生率显著低于对照组（22.8% vs 44.0%），优势比[OR]为0.38 [95% CI, 0.20 ~ 0.72]；002)和POD 3 (7.6% vs 19.8%;或者,0.33(95%可信区间,0.13 - -0.84);P = .02点)。两组患者术后抑郁、焦虑评分均无差异。术后前24小时氢吗啡酮用量(3.0[范围，2.8-3.3]mg vs 3.2[范围，2.9-3.4]mg; P =。[3-4]对[3-5]分；P < 0.05。0.001)，艾氯胺酮组明显低于对照组。在多变量logistic回归中，术前抑郁（OR, 1.31; 95% CI, 1.01-1.70）和焦虑（OR, 1.67; 95% CI, 1.04-1.80）评分、麻醉时间（OR, 1.04; 95% CI, 1.00-1.08）和术后疼痛评分（OR, 1.92; 95% CI, 1.24-2.96）被确定为与PSD相关的危险因素。本试验结果显示术中输注艾氯胺酮对妇科腹腔镜手术患者PSD的发生率有预防作用。需要进一步的研究来证实这些结果。中国临床试验注册号：ChiCTR2100048587
This randomized clinical trial examines the effect of intraoperative esketamine infusion on incidence of sleep disturbance following gynecological laparoscopic surgery. Does intravenous infusion of esketamine prevent postoperative sleep disturbance (PSD) at days 1 and 3 after gynecological laparoscopic surgery? In this randomized clinical trial of 183 female patients who underwent gynecological laparoscopic surgery in China, esketamine significantly decreased the incidence of PSD. Findings of this trial indicate that intraoperative esketamine infusion had a prophylactic effect on the incidence of PSD in patients who underwent gynecological laparoscopic surgery; further studies are needed to confirm these findings. Postoperative sleep disturbance (PSD) is common in patients after surgery. To examine the effect of intraoperative esketamine infusion on the incidence of PSD in patients who underwent gynecological laparoscopic surgery. This single-center, double-blind, placebo-controlled randomized clinical trial was conducted from August 2021 to April 2022 in the First Affiliated Hospital of Zhengzhou University in China. Participants included patients aged 18 to 65 years with an American Society of Anesthesiologist Physical Status classification of I to III (with I indicating a healthy patient, II a patient with mild systemic disease, and III a patient with severe systemic disease) who underwent gynecological laparoscopic surgery. Patients were randomly assigned to either the esketamine group or control group. Data were analyzed using the per protocol principle. Patients in the esketamine group received a continuous infusion of esketamine, 0.3 mg/kg/h, intraoperatively. Patients in the control group received an equivalent volume of saline. The primary outcome was the incidence of PSD on postoperative days (PODs) 1 and 3. Postoperative sleep disturbance was defined as a numeric rating scale score of 6 or higher or an Athens Insomnia Scale score of 6 points or higher. The secondary outcomes included postoperative anxiety and depression scores using the Hospital Anxiety and Depression Scale, postoperative pain using the visual analog scale, postoperative hydromorphone consumption, and risk factors associated with PSD. A total of 183 female patients were randomized to the control group (n = 91; median [IQR] age, 45 [35-49] years) and the esketamine group (n = 92; median [IQR] age, 43 [32-49] years). The incidence of PSD in the esketamine group was significantly lower than in the control group on POD 1 (22.8% vs 44.0%; odds ratio [OR], 0.38 [95% CI, 0.20-0.72]; P = .002) and POD 3 (7.6% vs 19.8%; OR, 0.33 [95% CI, 0.13-0.84]; P = .02). There were no differences in postoperative depression and anxiety scores between the 2 groups. Postoperative hydromorphone consumption in the first 24 hours (3.0 [range, 2.8-3.3] mg vs 3.2 [range, 2.9-3.4] mg; P = .04) and pain scores on movement (3 [3-4] vs 4 [3-5] points; P < .001) were significantly lower in the esketamine group than in the control group. On multivariable logistic regression, preoperative depression (OR, 1.31; 95% CI, 1.01-1.70) and anxiety (OR, 1.67; 95% CI, 1.04-1.80) scores, duration of anesthesia (OR, 1.04; 95% CI, 1.00-1.08), and postoperative pain score (OR, 1.92; 95% CI, 1.24-2.96) were identified as risk factors associated with PSD. Results of this trial showed the prophylactic effect of intraoperative esketamine infusion on the incidence of PSD in patients who underwent gynecological laparoscopic surgery. Further studies are needed to confirm these results. Chinese Clinical Trial Registry Identifier: ChiCTR2100048587
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影响因子：
10.6
作者：
Singh, Jaskaran B.;Fedgchin, Maggie;Van Nueten, Luc
通讯作者：
Van Nueten, Luc
DOI：
10.1176/appi.ajp.2013.13030392
发表时间：
2013-10
期刊：
The American journal of psychiatry
影响因子：
--
作者：
Murrough JW;Iosifescu DV;Chang LC;Al Jurdi RK;Green CE;Perez AM;Iqbal S;Pillemer S;Foulkes A;Shah A;Charney DS;Mathew SJ
通讯作者：
Mathew SJ
影响因子：
3.4
作者：
Duan, Guangyou;Wang, Kai;Li, Hong
通讯作者：
Li, Hong
影响因子：
6.9
作者：
Liverant, Gabrielle, I;Hall, Kimberly A. Arditte;Pizzagalli, Diego A.
通讯作者：
Pizzagalli, Diego A.
影响因子：
3.9
作者：
Cai J;Chen Y;Hao X;Zhu X;Tang Y;Wang S;Zhu T
通讯作者：
Zhu T