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低剂量罗哌卡因-芬太尼脊麻联合卡贝缩宫素用于剖宫产:一项随机双盲非劣效性试验
Authors Li M , Xie G, Chu L, Lu Y, Xu T, Li Y
Received 5 April 2025
Accepted for publication 27 August 2025
Published 2 September 2025 Volume 2025:18 Pages 4539—4550
DOI https://doi.org/10.2147/JPR.S532485
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Jinlei Li
Min Li,1 Guohao Xie,2 Lihua Chu,2 Yefang Lu,1 Tingting Xu,1 Yan Li3
1Department of Anesthesiology, the First Hospital of Fuyang, Hangzhou, People’s Republic of China; 2Department of Anesthesiology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China; 3Department of National Institute of Traditional Chinese Medicine Constitution and Preventive Medicine, Beijing University of Chinese Medicine, Beijing, People’s Republic of China
Correspondence: Min Li, Department of Anesthesiology, the First Hospital of Fuyang, Hangzhou, People’s Republic of China, Email 15857134355@163.com
Purpose: Intrathecal fentanyl improves intraoperative analgesia and reduces hypotension by enhancing subtherapeutic local anesthetic doses during cesarean sections. This study explores whether these advantages are affected by the negative circulatory effects of carbetocin after delivery.
Patients and Methods: This randomized double-blind, non-inferiority trial was conducted at a tertiary hospital in China. Sixty patients who underwent cesarean section, with singletons, were randomly assigned to receive either spinal anesthetic 15 mg ropivacaine combined with 10 μg fentanyl (Group F) or 16.5 mg ropivacaine (Group R). Slow intravenous carbetocin was routinely administered after delivery. Primary outcomes included hypotension incidence and anesthesia success rate (non-inferiority margin of 0.20). Secondary outcomes included analgesic supplementation time after anesthesia, vasopressor use, neonatal outcomes, patient satisfaction with anesthesia and postoperative analgesia, and adverse event incidence.
Results: The incidence of hypotension in Groups F and R was 73.3% and 96.7%, and the success rate of anesthesia was 93.3% and 66.7%, respectively. Compared with Group R, Group F showed superior results in terms of the incidence of hypotension (difference: − 23.3%; 95% confidence interval [CI], − 40.4 to − 6.2; P superiority 2-sided < 0.05) and the success rate of anesthesia (difference: 26.6%; 95% CI, 7.5 to 45.7; P superiority 2-sided < 0.05). Group F experienced longer pain relief, required less vasopressors, and reported less transient chest tightness. No significant differences were observed in other outcomes.
Conclusion: Low-dose ropivacaine combined with fentanyl remains a recommended choice for spinal anesthesia in cesarean sections, alongside carbetocin administration.
Keywords: cesarean section, hypotension, fentanyl, spinal anesthesia