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Intraoperative ketamine for reduction in postpartum depressive symptoms after cesarean delivery: A double‐blind, randomized clinical trial

机译:术中氯胺酮用于减少剖宫产后产后抑郁症状:双盲,随机临床试验

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Background Postpartum depression (PPD) is a common mental disease happens in perinatal period. Ketamine as an anesthesia and analgesia drug has been used for a long time. In recent years, ketamine is proved to have an antidepression effect with a single administration. We hypothesized that intraoperative ketamine can reduce postpartum depressive symptoms after cesarean delivery. Methods In a randomized, double‐blind, placebo‐controlled study trail, healthy women scheduled for cesarean delivery were randomly assigned to receive intravenous ketamine (0.25?mg/kg diluted to 5?ml with 0.9% saline) or placebo (5?ml of 0.9% saline) within 5?min following clamping of the neonatal umbilical cord. The primary outcome was the degree of postpartum depressive symptoms, which was evaluated by Edinburgh Postnatal Depression Scale (EPDS, a threshold of 9/10 was used) at 1?week, 2?weeks, and 1?month after delivery. The secondary outcome was the numerical rating scale (NRS) score of pain at 2?days postpartum. This trail is registered in the Chinese Clinical Trial Registry, number ChiCTR1900022464. Results Between 26 January 2019 and 15 July 2019, 502 subjects were screened and 330 were randomly allocated: 165 (50%) to the ketamine group and 165 (50%) to the placebo group. There were significant differences in the degree of postpartum depressive symptoms between subjects in the ketamine group and the placebo group at 1?week postpartum (13.1% vs. 22.6%, respectively; p?=?.029). However, no difference was found between subjects in the two groups at 2?weeks (11.8% vs. 16.8%, respectively; p?=?.209) and 1?month postpartum (10.5% vs. 14.2%, respectively; p?=?.319). The NRS score of wound pain (3.0?±?0.9 vs. 4.0?±?1.0, respectively; p??.001) and uterine contraction pain (3.0?±?0.9 vs. 4.1?±?0.9, respectively; p??.001) was lower in the ketamine group at 2?days postpartum compared with placebo group. The prevalence of headache, hallucination, and dizziness was higher in the ketamine group than the placebo group during the operation. Conclusions Operative intravenous ketamine (0.25?mg/kg) can reduce the postpartum depressive symptoms for 1?week. The long‐time effect is remained to be seen.
机译:背景产后抑郁症(PPD)是一种常见的精神疾病发生在围产期。氯胺酮作为麻醉和镇痛药物已经使用了很长一段时间。近年来,氯胺酮被证明有一个管理的抗抑郁作用。我们推测,术中氯胺酮剖宫产后减少产后抑郁症状。方法在一项随机,双盲,安慰剂对照研究步道,预定剖宫产健康妇女被随机分配接受静脉内氯胺酮(0.25?毫克/千克稀释至5?毫升0.9%盐水)或安慰剂(5?毫升的5'以下新生儿脐带的夹紧分钟内0.9%的盐水)。主要的结果是产后抑郁症状,这是由爱丁堡产后抑郁量表评估的程度(EPDS,使用9/10的阈值)在1〜周,2?周,1?月分娩后。次要结果是疼痛的数字评定量表(NRS)评分为2?天产后。这条古道是注册在中国临床试验注册,编号ChiCTR1900022464。结果之间2019年1月26日和2019年7月15日,502名受试者进行筛选和330被随机分配:165(50%)到氯胺酮组和165(50%),安慰剂组。有在的氯胺酮组中的受试者和安慰剂组之间产后抑郁症状的程度显著差异在第1周产后?(13.1%对22.6%,分别; P =?029)。然而,没有差异,在两组受试者之间在2找到周(11.8%对16.8%,分别; P =?209)4和产后1个月(10.5%对14.2%,; 2 P 3 =?319)。该NRS分数的伤口疼痛(3.0±0.9与4.0±1.0,分别;?????P <?001)?和子宫收缩的疼痛(3.0±0.9与4.1±0.9,分别;?2 P <??001)在2是氯胺酮组低?天产后与安慰剂组进行比较。头痛,幻觉和头晕的患病率在操作过程中比安慰剂组氯胺酮组中更高。结论手术静脉内氯胺酮(0.25?毫克/千克),可以减少1?周产后抑郁症状。在较长时间的效果仍有待观察。

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