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丙泊酚对肥胖患者无痛胃镜检查期间呼吸相关不良事件发生率的影响:一项前瞻性随机临床试验

Effects of ciprofol on respiratory-related adverse incidence in patients with obesity during painless gastroscopy: a prospective, randomized clinical trial.

作者信息

Zhang Yanjing, Xie Danru, Li Feifei, Che Mengjiao, Yang Yaoheng, Li Geng, Zhang Yiwen

机构信息

Department of Anesthesiology, Shunde Hospital of Southern Medical University (The First People's Hospital, Shunde District, Foshan City), Foshan, 528308, China.

出版信息

Perioper Med (Lond). 2025 Apr 29;14(1):49. doi: 10.1186/s13741-025-00529-5.

Abstract

BACKGROUND

Ciprofol is an intravenous anesthetic agent which in low doses produces sedation. It was developed via structural modification of propofol. Ciprofol is claimed to reduce respiratory depression. The object of the present study was to investigate whether or not ciprofol did actually reduce respiratory depression or not in patients with obesity undergoing gastroscopy.

METHODS

A total of 84 patients with obesity scheduled for gastroscopy were enrolled. The participants were randomly allocated to receive sedation with ciprofol (group C) or propofol (group P). The primary outcome was the incidence of respiratory-related adverse events (AEs), whereas the secondary outcomes were the incidence of further intraoperative and postoperative AEs; procedure and anesthesia success rates; Narcotrend index (NI); induction dosage; procedure time; recovery time; discharge time; and satisfaction ratings from the patients, anesthesiologists, and endoscopists.

RESULTS

The incidence of respiratory-related AEs was significantly lower in group C than in group P (17.5% vs. 57.5%; P < 0.001). The occurrence of hypotension and movement during procedural events in group C was markedly reduced compared with that in group P (P = 0.024 and 0.007, respectively). No notable differences were observed in the occurrence of additional AEs or in the success rates of the procedure and anesthesia between the two groups (P > 0.05). The three-point satisfaction levels were comparable between the groups (P > 0.05).

CONCLUSIONS

0.4 mg/kg of ciprofol provides anesthesia comparable with 2.0 mg/kg of propofol. However, it is related to reduced respiratory-related AEs and hypotension during gastroscopy in patients with obesity; thus, ciprofol is preferred to propofol for anesthesia in obese patients.

TRIAL REGISTRATION

This study was registered in the Chinese Clinical Trial Registry (KYLS20230625; first registration date: 29/06/2023).

摘要

背景

环泊酚是一种静脉麻醉剂,小剂量使用时可产生镇静作用。它是通过对丙泊酚进行结构修饰而研发的。据称环泊酚可减轻呼吸抑制。本研究的目的是调查环泊酚在接受胃镜检查的肥胖患者中是否真的能减轻呼吸抑制。

方法

共纳入84例计划进行胃镜检查的肥胖患者。参与者被随机分配接受环泊酚镇静(C组)或丙泊酚镇静(P组)。主要结局是呼吸相关不良事件(AE)的发生率,次要结局是术中及术后进一步不良事件的发生率、手术和麻醉成功率、脑电双频指数(NI)、诱导剂量、手术时间、恢复时间、出院时间以及患者、麻醉医生和内镜医生的满意度评分。

结果

C组呼吸相关AE的发生率显著低于P组(17.5%对57.5%;P < 0.001)。与P组相比,C组在手术过程中低血压和体动的发生率明显降低(分别为P = 0.024和0.007)。两组在额外不良事件的发生情况或手术及麻醉成功率方面未观察到显著差异(P > 0.05)。两组的三点满意度水平相当(P > 0.05)。

结论

0.4mg/kg的环泊酚提供的麻醉效果与2.0mg/kg的丙泊酚相当。然而,它与肥胖患者胃镜检查期间呼吸相关AE和低血压的减少有关;因此,在肥胖患者麻醉中,环泊酚比丙泊酚更可取。

试验注册

本研究在中国临床试验注册中心注册(KYLS20230625;首次注册日期:2023年6月29日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0699/12038989/0c9f3f99983c/13741_2025_529_Fig1_HTML.jpg

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