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不同剂量盐酸艾司氯胺酮注射液用于甲状腺癌根治性甲状腺切除术患者的疗效和安全性:一项随机试验

Efficacy and safety of esketamine hydrochloride injection at different dosages for patients undergoing radical thyroidectomy for thyroid cancer: a randomized trial.

作者信息

Luo Yihuan, Fang Hua

机构信息

Department of Anesthesiology, The First Affiliated Hospital of Xi'an Medical University, Xi'an, 710077, China.

Department of Anesthesiology, The Second People's Hospital of Guiyang/The Affiliated Jinyang Hospital of Guizhou Medical University, Guiyang, 550081, China.

出版信息

BMC Anesthesiol. 2025 Jul 1;25(1):307. doi: 10.1186/s12871-025-03174-z.

DOI:10.1186/s12871-025-03174-z
PMID:40596895
Abstract

OBJECTIVE

This study aims to the combination of remimazolam toluene sulfonate and esketamine hydrochloride in reducing postoperative complications and improving recovery outcomes in thyroid surgery patients.

METHODS

One hundred twenty patients undergoing radical thyroidectomy were randomly assigned to four groups: control group (Group C) and three esketamine groups (Groups S1, S2, S3). Before peeling, groups S1, S2, and S3 were administered with 0.15, 0.25, and 0.35 mg/kg of esketamine via slow intravenous injection, respectively. The primary outcomes was recovery quality (QoR-15). Secondary outcomes included postoperative pain (NRS scores), incidence of coughing (Minogue score), hemodynamic stability, emotional recovery (HADS scores), extubation time, adverse reactions, and sufentanil consumption.

RESULTS

Baseline data showed no significant differences (p > 0.05). Pain and HADS scores were significantly lower in Groups S2 and S3 (p < 0.05). QoR-15 scores were significantly higher in all esketamine groups (p < 0.05). Postoperative recovery and extubation times were longer in Groups S2 and S3 (p < 0.05), with Group S3 having the longest. Postoperative cough severity and incidence were significantly lower in Groups S2 and S3 (p < 0.05). HR and SBP increased at t1 in Groups S2 and S3 but normalized by t4, with less pronounced changes in Group S2. No significant differences in adverse reactions (p > 0.05).

CONCLUSION

Esketamine at doses of 0.25 mg/kg/h and 0.35 mg/kg/h improves recovery, reduces pain and coughing, and maintains hemodynamic stability. A dose of 0.25 mg/kg/h offers optimal clinical benefits with faster recovery.

摘要

目的

本研究旨在探讨甲苯磺酸瑞马唑仑与盐酸艾司氯胺酮联合应用对甲状腺手术患者术后并发症的影响及对恢复结局的改善作用。

方法

120例行根治性甲状腺切除术的患者被随机分为四组:对照组(C组)和三个艾司氯胺酮组(S1组、S2组、S3组)。在剥离前,S1组、S2组和S3组分别通过缓慢静脉注射给予0.15、0.25和0.35mg/kg的艾司氯胺酮。主要结局指标为恢复质量(QoR-15)。次要结局指标包括术后疼痛(NRS评分)、咳嗽发生率(Minogue评分)、血流动力学稳定性、情绪恢复(HADS评分)、拔管时间、不良反应及舒芬太尼用量。

结果

基线数据显示无显著差异(p>0.05)。S2组和S3组的疼痛和HADS评分显著更低(p<0.05)。所有艾司氯胺酮组的QoR-15评分显著更高(p<0.05)。S2组和S3组的术后恢复和拔管时间更长(p<0.05),S3组最长。S2组和S3组的术后咳嗽严重程度和发生率显著更低(p<0.05)。S2组和S3组在t1时心率和收缩压升高,但在t4时恢复正常,S2组变化较不明显。不良反应无显著差异(p>0.05)。

结论

0.25mg/kg/h和0.35mg/kg/h剂量的艾司氯胺酮可改善恢复情况,减轻疼痛和咳嗽,并维持血流动力学稳定性。0.25mg/kg/h的剂量具有更快恢复的最佳临床效益。

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