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已发表论文
芬太尼与艾司氯胺酮在宫腔镜镇痛中的 ED90 和临床结局比较：一项两部分、随机、双盲试验
Authors Du J , Li C, Huang M, Qin X
Received 15 October 2025
Accepted for publication 9 January 2026
Published 13 January 2026 Volume 2026:20 574516
DOI https://doi.org/10.2147/DDDT.S574516
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Yan Zhu
Jun Du, Chan Li, Mei Huang, Xiarong Qin
Department of Anesthesiology, Zhejiang Hospital, Hangzhou, Zhejiang, 310030, People’s Republic of China
Correspondence: Xiarong Qin, Department of Anesthesiology, Zhejiang Hospital, Hangzhou, Zhejiang, 310030, People’s Republic of China, Email zjyy_qxr@163.com
Background: Hysteroscopy is a minimally invasive procedure that can nonetheless elicit considerable pain, especially during cervical dilation. While fentanyl is widely used for analgesia, its application is limited by side effects such as respiratory depression. Esketamine, a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, has emerged as a promising alternative due to its potent analgesic effects and safer profile. This study aimed to determine and compare the effective dose 90 (ED90) of these drugs for preventing physical movements and to evaluate their efficacy and safety.
Methods: This two-part, prospective, randomized, double-blind trial enrolled patients scheduled for hysteroscopy. In Part 1, the ED90 of intravenous fentanyl (0.25– 2.00 μg/kg) and esketamine (0.15– 0.50 mg/kg) was determined using a sequential allocation biased-coin design (SABCD). The SABCD was implemented independently for each drug, with a targeted enrollment of 60 participants per group; ultimately, 56 participants per group were included in this dose-finding phase. In Part 2, clinical outcomes and adverse events were compared in an additional set of 56 patients per group, all of whom received the predetermined ED90 of their assigned drug.
Results: The ED90 of fentanyl was 1.424 μg/kg (95% confidence interval [CI]: 1.322– 1.618 μg/kg), compared to 0.423 mg/kg (95% CI: 0.368– 0.569 mg/kg) for esketamine. The two groups exhibited comparable efficacy in physical movements inhibition and total propofol consumption. However, the esketamine group demonstrated a markedly improved safety and recovery profile. Specifically, patients receiving esketamine reported significantly less propofol injection pain (fentanyl group vs esketamine group, 25% vs 7.1%; relative risk [RR], 0.4; 95% CI: 0.2– 0.8; P = 0.019), experienced significantly faster emergence from anesthesia (7.0 [5.0, 9.5] vs 6.0 [5.0, 8.0]; median difference [MD], − 1.0; 95% CI: − 2.0– 0; P = 0.029), and maintained better hemodynamic stability. Crucially, the incidence of respiratory depression was significantly lower in the esketamine group (26.8% vs 3.6%; RR, 0.2; 95% CI: 0.06– 0.6; P = 0.001). Furthermore, the esketamine group showed a significantly greater reduction in Hospital Anxiety and Depression Scale (HADS) scores at the one-month follow-up than the fentanyl group (4.0 [3.0, 4.0] vs 2.0 [1.0, 2.0]; MD, − 2.0; 95% CI: − 2.0–− 2.0; P < 0.001).
Conclusion: At equipotent ED90 doses, esketamine provides analgesia equivalent to fentanyl during hysteroscopy, while conferring additional advantages, such as reduced injection pain, faster emergence, superior cardiorespiratory stability, and potential psychological benefits.
Registration: Chinese Clinical Trial Registry ChiCTR2500106429.
Keywords: fentanyl, esketamine, ED90, hysteroscopy, analgesia
Department of Anesthesiology, Zhejiang Hospital, Hangzhou, Zhejiang, 310030, People’s Republic of China
Correspondence: Xiarong Qin, Department of Anesthesiology, Zhejiang Hospital, Hangzhou, Zhejiang, 310030, People’s Republic of China, Email zjyy_qxr@163.com
Background: Hysteroscopy is a minimally invasive procedure that can nonetheless elicit considerable pain, especially during cervical dilation. While fentanyl is widely used for analgesia, its application is limited by side effects such as respiratory depression. Esketamine, a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, has emerged as a promising alternative due to its potent analgesic effects and safer profile. This study aimed to determine and compare the effective dose 90 (ED90) of these drugs for preventing physical movements and to evaluate their efficacy and safety.
Methods: This two-part, prospective, randomized, double-blind trial enrolled patients scheduled for hysteroscopy. In Part 1, the ED90 of intravenous fentanyl (0.25– 2.00 μg/kg) and esketamine (0.15– 0.50 mg/kg) was determined using a sequential allocation biased-coin design (SABCD). The SABCD was implemented independently for each drug, with a targeted enrollment of 60 participants per group; ultimately, 56 participants per group were included in this dose-finding phase. In Part 2, clinical outcomes and adverse events were compared in an additional set of 56 patients per group, all of whom received the predetermined ED90 of their assigned drug.
Results: The ED90 of fentanyl was 1.424 μg/kg (95% confidence interval [CI]: 1.322– 1.618 μg/kg), compared to 0.423 mg/kg (95% CI: 0.368– 0.569 mg/kg) for esketamine. The two groups exhibited comparable efficacy in physical movements inhibition and total propofol consumption. However, the esketamine group demonstrated a markedly improved safety and recovery profile. Specifically, patients receiving esketamine reported significantly less propofol injection pain (fentanyl group vs esketamine group, 25% vs 7.1%; relative risk [RR], 0.4; 95% CI: 0.2– 0.8; P = 0.019), experienced significantly faster emergence from anesthesia (7.0 [5.0, 9.5] vs 6.0 [5.0, 8.0]; median difference [MD], − 1.0; 95% CI: − 2.0– 0; P = 0.029), and maintained better hemodynamic stability. Crucially, the incidence of respiratory depression was significantly lower in the esketamine group (26.8% vs 3.6%; RR, 0.2; 95% CI: 0.06– 0.6; P = 0.001). Furthermore, the esketamine group showed a significantly greater reduction in Hospital Anxiety and Depression Scale (HADS) scores at the one-month follow-up than the fentanyl group (4.0 [3.0, 4.0] vs 2.0 [1.0, 2.0]; MD, − 2.0; 95% CI: − 2.0–− 2.0; P < 0.001).
Conclusion: At equipotent ED90 doses, esketamine provides analgesia equivalent to fentanyl during hysteroscopy, while conferring additional advantages, such as reduced injection pain, faster emergence, superior cardiorespiratory stability, and potential psychological benefits.
Registration: Chinese Clinical Trial Registry ChiCTR2500106429.
Keywords: fentanyl, esketamine, ED90, hysteroscopy, analgesia