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不同稀释度舒芬太尼预处理减轻胃肠内镜检查中丙泊酚注射痛的比较:一项随机对照研究。

Comparison of pre-treatment with different diluted sufentanil in reducing propofol injection pain in gastrointestinal endoscopy: A randomized controlled study.

作者信息

Su Qian, He Shu, Li Lu, Wei Xiangqing, Sun Xin, Yang Xuefeng, Du Boxiang, Yao Lei

机构信息

Department of Anesthesiology, Nantong First People's Hospital, Nantong, Jiangsu, China.

Department of Epidemiology and Biostatistics, School of Public Health, Nantong University, Nantong, Jiangsu, China.

出版信息

PLoS One. 2025 May 29;20(5):e0325113. doi: 10.1371/journal.pone.0325113. eCollection 2025.

Abstract

BACKGROUND

This study aimed to investigate the efficacy of pre-treatment with different concentrations of sufentanil in mitigating propofol injection-induced pain.

METHODS

This study included 421 patients who were scheduled for gastrointestinal endoscopy between June 2023 and December 2024. Participants were randomly assigned to one of the four groups with different concentrations sufentanil: 0 µg/mL group(0.9% normal saline), 0.5 µg/mL group, 1 µg/mL group and 5 µg/mL group.

RESULTS

Among the four groups, the rates of pain relief were 82 (77.4%), 93 (89.4%), 96 (89.7%), and 91 (87.5%), respectively. Compared to the 0 µg/mL group, the other groups demonstrated significantly reduced pain following propofol injection (p < 0.05). The recovery times were 14.59 ± 3.92 min, 15.13 ± 3.20 min, 14.27 ± 3.06 min, and 15.57 ± 3.24 min, respectively. Notably, the 1 µg/mL group did not exhibit a prolonged recovery time compared to the 0 µg/mL group. The total propofol consumption was recorded as 218.5 ± 36.8 mg, 196.7 ± 31.0 mg, 183.8 ± 25.0 mg, and 189.6 ± 31.4 mg, respectively, with the 1 µg/mL group showing the lowest total propofol consumption among the groups. The incidences of adverse events (AEs) were 61.3%, 70.2%, 58.9%, and 76.9%, respectively. In comparison to the 1 µg/mL group, the 5 µg/mL group exhibited a higher incidence of AEs. Furthermore, multivariate analysis indicated that a 5 µg/mL dilution of sufentanil increases the risk of AEs (p < 0.05).

CONCLUSIONS

The 1 µg/mL group demonstrated greater safety and efficacy when combined with propofol.

TRIAL REGISTRATION

The study has been registered in the Chinese Clinical Trial Registry (ChiCTR). Link of the registry: http://www.chictr.org.cn. Date of registration: 2023/06/12. Trial registration number: ChiCTR2300072402.

摘要

背景

本研究旨在探讨不同浓度舒芬太尼预处理减轻丙泊酚注射痛的疗效。

方法

本研究纳入了421例计划于2023年6月至2024年12月行胃肠内镜检查的患者。参与者被随机分配到四组不同浓度舒芬太尼组之一:0 μg/mL组(0.9%生理盐水)、0.5 μg/mL组、1 μg/mL组和5 μg/mL组。

结果

四组中,疼痛缓解率分别为82例(77.4%)、93例(89.4%)、96例(89.7%)和91例(87.5%)。与0 μg/mL组相比,其他组丙泊酚注射后的疼痛明显减轻(p<0.05)。恢复时间分别为14.59±3.92分钟、15.13±3.20分钟、14.27±3.06分钟和15.57±3.24分钟。值得注意的是,1 μg/mL组与0 μg/mL组相比,恢复时间并未延长。丙泊酚总消耗量分别记录为2l8.5±36.8 mg、196.7±31.0 mg、183.8±25.0 mg和189.6±31.4 mg,1 μg/mL组丙泊酚总消耗量在各组中最低。不良事件(AE)发生率分别为61.3%、70.2%、58.9%和76.9%。与1 μg/mL组相比,5 μg/mL组AE发生率更高。此外,多因素分析表明,舒芬太尼5 μg/mL稀释液会增加AE风险(p<0.05)。

结论

1 μg/mL组与丙泊酚联合使用时显示出更高的安全性和疗效。

试验注册

本研究已在中国临床试验注册中心(ChiCTR)注册。注册链接:http://www.chictr.org.cn。注册日期:2023/06/12。试验注册号:ChiCTR2300072402。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec72/12121801/acb3de59bef5/pone.0325113.g001.jpg

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