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依托咪酯-右美托咪定与舒芬太尼-右美托咪定用于肺肿瘤经皮射频消融术镇静镇痛的对比研究:一项随机双盲临床试验。

A comparative study of esketamine-dexmedetomidine and sufentanil-dexmedetomidine for sedation and analgesia in lung tumor percutaneous radiofrequency ablation (PRFA): a randomized double-blind clinical trial.

机构信息

The Fourth Clinical School of Medicine, Zhejiang Chinese Medical University, Hangzhou, 310006, China.

Department of Anesthesiology, Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou, 310006, China.

出版信息

BMC Anesthesiol. 2023 Sep 8;23(1):304. doi: 10.1186/s12871-023-02266-y.

Abstract

OBJECTIVE

To observe and evaluate the effectiveness and safety of Esketamine or Sufentanil combined with Dexmedetomidine for sedation and analgesia in lung tumor percutaneous radiofrequency ablation (PRFA) to provide a clinical basis for the optimization of sedation and analgesia in lung tumor PRFA protocols outside the operating room.

METHODS

In this trial, 44 patients aged 37 to 84 undergoing lung tumor PRFA were enrolled and assigned to Group E (n = 22, Esketamine 0.2 mg/kg) or Group S (n = 22,Sufentanil 0.1 μg/kg ). Dexmedetomidine was infused intravenously as a sedative in both groups. The modified observer's assessment of alertness and sedation scale (MOAAS), physical movement pain scale, intraoperative vital signs, anesthesia recovery time, radiologist and patient satisfaction rates, incidence of respiratory depression, and incidence of postoperative nausea and vomiting were recorded.

RESULTS

Although there was no significant difference in the physical movement pain scale, blood oxygen saturation or incidence of perioperative adverse events between the two groups during ablation, the MOAAS, mean arterial pressure (MAP) and heart rate (HR) were higher in Group E than in Group S. The anesthesia recovery time was shorter in Group E than in Group S, and radiologist satisfaction was better in Group E than in Group S, but there was no significant difference between the two groups in terms of patient satisfaction.

CONCLUSION

Esketamine or Sufentanil combined with Dexmedetomidine is safe for lung tumor PRFA. However, in elderly patients with multiple underlying diseases, low-dose Esketamine combined with Dexmedetomidine has fewer hemodynamic effects on patients, milder respiratory depression, shorter recovery time, and better radiologist satisfaction because of its better controllability of sedation depth.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (Registration number#ChiCTR ChiCTR21000500 21); Date of Registration: 16/08/2021.

摘要

目的

观察和评估依托咪酯或舒芬太尼联合右美托咪定用于肺肿瘤经皮射频消融(PRFA)镇静镇痛的效果和安全性,为优化肺肿瘤 PRFA 术间镇静镇痛方案提供临床依据。

方法

本试验纳入 44 例行肺肿瘤 PRFA 的患者,年龄 37~84 岁,采用随机数字表法分为依托咪酯组(E 组,n=22,依托咪酯 0.2mg/kg)和舒芬太尼组(S 组,n=22,舒芬太尼 0.1μg/kg)。两组均静脉泵注右美托咪定镇静。记录改良警觉/镇静评分(MOAAS)、躯体运动疼痛评分、术中生命体征、麻醉恢复时间、放射科医生和患者满意度、呼吸抑制发生率、术后恶心呕吐发生率。

结果

两组患者在消融过程中的躯体运动疼痛评分、血氧饱和度或围术期不良反应发生率比较,差异无统计学意义;E 组 MOAAS、平均动脉压(MAP)和心率(HR)高于 S 组,麻醉恢复时间短于 S 组,放射科医生满意度高于 S 组,但两组患者满意度比较,差异无统计学意义。

结论

依托咪酯或舒芬太尼联合右美托咪定用于肺肿瘤 PRFA 是安全的。但在伴有多种基础疾病的老年患者中,因依托咪酯对患者血流动力学影响较小、呼吸抑制较轻、苏醒时间较短、镇静深度可控性较好,其联合右美托咪定的方案在放射科医生满意度方面优于舒芬太尼联合右美托咪定。

试验注册

中国临床试验注册中心(注册号:ChiCTR ChiCTR2100050021);注册日期:2021 年 08 月 16 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e483/10486108/d89b20a88e96/12871_2023_2266_Fig6_HTML.jpg

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