RETRACTED: Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery

作者：Lili Xu, Chun Wang, Chun-Mei Deng, Shaobing Dai, Qun Zhou, Yong‐Bao Peng, Hong‐yan Shou, Yinqiu Han, Yu Jing, Chaohui Liu, Feng Xia, Suqin Zhang, Dong‐Xin Wang, Xinzhong Chen · 发表于：JAMA Network Open · 年份：2023 · DOI：10.1001/jamanetworkopen.2023.9321 · 被引用次数：71 · 研究领域：Anesthesia and Pain Management、Anesthesia and Sedative Agents、Maternal Mental Health During Pregnancy and Postpartum

Importance: Epidural anesthesia is a primary choice for cesarean delivery, but supplemental analgesics are often required to relieve pain during uterine traction. Objective: To investigate the sedative and analgesic effects of intravenous esketamine administered before childbirth via cesarean delivery with the patient under epidural anesthesia. Design, Setting, and Participants: This multicenter, double-blind randomized clinical trial assessed 903 women 18 years or older who had full-term single pregnancy and were scheduled for elective cesarean delivery with epidural anesthesia in 5 medical centers in China from September 18, 2021, to September 20, 2022. Intervention: Patients were randomized to receive intravenous injection of 0.25 mg/kg of esketamine or placebo before incision. Main Outcomes and Measures: The coprimary outcomes included scores on the numeric rating scale of pain (an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain; a difference of ≥1.65 points was clinically meaningful) and Ramsay Sedation Scale (a 6-point scale, with 1 indicating restlessness and 6 indicating deep sleep without response; a difference of ≥2 points was clinically meaningful) immediately after fetal delivery. Secondary outcomes included neonatal Apgar score assessed at 1 and 5 minutes after birth. Results: A total of 600 women (mean [SD] age, 30.7 [4.3] years) were enrolled and randomized; all were included in the intention-to-treat analysis. Immediately after fetal...