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鞘内注射亚临床剂量氯胺酮对剖宫产术后抑郁和疼痛的影响:一项前瞻性、随机、双盲对照试验。

The effect of a subclinical dose of esketamine on depression and pain after cesarean section: A prospective, randomized, double-blinded controlled trial.

机构信息

Department of Anesthesiology, The Affiliated Yongchuan Hospital of Chongqing Medical University, Chongqing, China.

Department of Anesthesiology, Affiliated Hospital of Sichuan Nursing Vocational College, Chengdu, China.

出版信息

Medicine (Baltimore). 2024 Nov 1;103(44):e40295. doi: 10.1097/MD.0000000000040295.

Abstract

BACKGROUND

The aim of this randomized, double-blind placebo-controlled clinical trial was to study the effects of subclinical doses of esketamine on postpartum depression and pain following elective cesarean sections.

METHODS

This randomized, double-blind placebo-controlled trial included 150 pregnant women undergoing elective cesarean sections. After umbilical cord clamping, participants received either subclinical doses of esketamine (0.25 mg/kg, diluted in 10 mL of 0.9% saline) or a placebo (10 mL of 0.9% saline). The primary outcome measures were the incidence of postpartum depression (PPD) and postoperative pain. The Edinburgh Postnatal Depression Scale was used to evaluate PPD on days 3, 7, and 14 postpartum, with an Edinburgh Postnatal Depression Scale score ≥ 10 indicating PPD. Postoperative pain was assessed using the Visual Analog Scale (VAS) at 4, 24, and 48 hours post-surgery. Secondary outcomes included adverse reactions and Ramsay sedation scores at 5 and 15 minutes post-administration.

RESULTS

There were no significant differences in the incidence of PPD between the 2 groups on days 3, 7, and 14 postpartum (P > .05). The VAS scores showed significant differences between the 2 groups at 4 and 24 hours postoperatively (P < .05), but not at 48 hours (P > .05). The experimental group had significantly higher adverse reactions and Ramsay sedation scores 5 minutes post-administration compared to the control group (P < .05), but no significant differences were observed upon leaving the operating room (P > .05).

CONCLUSION

Subclinical doses of esketamine did not reduce the incidence of PPD at 14 days postpartum but did significantly lower VAS scores at 24 hours post-surgery. The experimental group experienced temporary increases in adverse reactions and Ramsay sedation scores shortly after administration.

摘要

背景

本随机、双盲、安慰剂对照临床试验旨在研究亚临床剂量的氯胺酮对选择性剖宫产术后产后抑郁和疼痛的影响。

方法

本随机、双盲、安慰剂对照试验纳入了 150 例行选择性剖宫产的孕妇。脐带夹闭后,参与者接受亚临床剂量氯胺酮(0.25mg/kg,溶于 10ml 0.9%生理盐水)或安慰剂(10ml 0.9%生理盐水)。主要结局指标为产后抑郁(PPD)和术后疼痛的发生率。采用爱丁堡产后抑郁量表(EPDS)于产后第 3、7、14 天评估 PPD,EPDS 评分≥10 分表示 PPD。术后采用视觉模拟评分法(VAS)于术后 4、24、48 小时评估疼痛。次要结局指标包括给药后 5、15 分钟的不良反应和 Ramsay 镇静评分。

结果

两组产后第 3、7、14 天的 PPD 发生率无统计学差异(P>.05)。VAS 评分显示两组术后 4、24 小时差异有统计学意义(P<.05),但 48 小时无差异(P>.05)。实验组给药后 5 分钟不良反应和 Ramsay 镇静评分明显高于对照组(P<.05),但离开手术室时无差异(P>.05)。

结论

亚临床剂量氯胺酮不能降低产后 14 天的 PPD 发生率,但明显降低术后 24 小时的 VAS 评分。实验组给药后即刻不良反应和 Ramsay 镇静评分暂时增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6fff/11537604/9e8e798a58a9/medi-103-e40295-g001.jpg

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