在脊髓麻醉下接受全膝关节置换术（TKADEX）的患者中使用右美托咪定（intranasal dexmedetomidine）进行预处理--一项前瞻性、双盲、随机对照试验

BJA open Pub Date : 2025-03-01 DOI:10.1016/j.bjao.2025.100382

Suvi-Maria Tiainen , Heta Heinonen , Atte Koskinen , Sanna Mäkelä , Ruut Laitio , Eliisa Löyttyniemi , Keijo Mäkelä , Teijo I. Saari , Panu Uusalo

{"title":"在脊髓麻醉下接受全膝关节置换术（TKADEX）的患者中使用右美托咪定（intranasal dexmedetomidine）进行预处理--一项前瞻性、双盲、随机对照试验","authors":"Suvi-Maria Tiainen , Heta Heinonen , Atte Koskinen , Sanna Mäkelä , Ruut Laitio , Eliisa Löyttyniemi , Keijo Mäkelä , Teijo I. Saari , Panu Uusalo","doi":"10.1016/j.bjao.2025.100382","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Previous studies have shown that perioperative use of adjuvants, such as the alpha-2 agonist dexmedetomidine, may reduce postoperative pain and opioid requirements. However, information about optimal dosing is lacking. We investigated if premedication with intranasal dexmedetomidine compared with placebo reduces postoperative pain in patients undergoing total knee arthroplasty under spinal anaesthesia.</div></div><div><h3>Methods</h3><div>This single-centre, double-blind, two-arm study compared premedication with intranasal dexmedetomidine (single 1 μg kg<sup>−1</sup> dose) to intranasal saline in 101 consecutive elective patients undergoing total knee arthroplasty under spinal anaesthesia. The primary outcome was postoperative pain measured with the numerical rating scale during the first 24 h. Secondary outcomes were postoperative opioid requirement, perioperative haemodynamic variables, requirement of additional intraoperative sedation, incidence of postoperative nausea and vomiting, and patient satisfaction at 30 days after surgery.</div></div><div><h3>Results</h3><div>Patients in the dexmedetomidine group had lower numerical rating scale scores [median (interquartile range) 2.0 (0.0–3.0)] at 3 h when compared with the control group [3.0 (2.0–4.0)] (<em>P</em>=0.037). Cumulative 24 h opioid requirements (in morphine equivalents) did not differ between dexmedetomidine [45 mg (30–68 mg)] and control groups [53 mg (38–88 mg)] (<em>P</em>=0.334). More patients in the dexmedetomidine group were satisfied with pain management in the ward (<em>P</em>=0.0013). The groups did not differ in the incidence of postoperative nausea and vomiting (<em>P</em>=0.310) or haemodynamic adverse events (<em>P</em>>0.27 for all).</div></div><div><h3>Conclusions</h3><div>Our results indicate that intranasal dexmedetomidine may reduce postoperative pain and the requirement for additional sedation and increase short-term patient satisfaction in patients undergoing total knee arthroplasty.</div></div><div><h3>Clinical trial registration</h3><div>ClinicalTrials.gov (NCT 04859283).</div></div>","PeriodicalId":72418,"journal":{"name":"BJA open","volume":"13 ","pages":"Article 100382"},"PeriodicalIF":0.0000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Premedication with intranasal dexmedetomidine in patients undergoing total knee arthroplasty under spinal anaesthesia (TKADEX)—a prospective, double-blinded, randomised controlled trial\",\"authors\":\"Suvi-Maria Tiainen , Heta Heinonen , Atte Koskinen , Sanna Mäkelä , Ruut Laitio , Eliisa Löyttyniemi , Keijo Mäkelä , Teijo I. Saari , Panu Uusalo\",\"doi\":\"10.1016/j.bjao.2025.100382\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Previous studies have shown that perioperative use of adjuvants, such as the alpha-2 agonist dexmedetomidine, may reduce postoperative pain and opioid requirements. However, information about optimal dosing is lacking. We investigated if premedication with intranasal dexmedetomidine compared with placebo reduces postoperative pain in patients undergoing total knee arthroplasty under spinal anaesthesia.</div></div><div><h3>Methods</h3><div>This single-centre, double-blind, two-arm study compared premedication with intranasal dexmedetomidine (single 1 μg kg<sup>−1</sup> dose) to intranasal saline in 101 consecutive elective patients undergoing total knee arthroplasty under spinal anaesthesia. The primary outcome was postoperative pain measured with the numerical rating scale during the first 24 h. Secondary outcomes were postoperative opioid requirement, perioperative haemodynamic variables, requirement of additional intraoperative sedation, incidence of postoperative nausea and vomiting, and patient satisfaction at 30 days after surgery.</div></div><div><h3>Results</h3><div>Patients in the dexmedetomidine group had lower numerical rating scale scores [median (interquartile range) 2.0 (0.0–3.0)] at 3 h when compared with the control group [3.0 (2.0–4.0)] (<em>P</em>=0.037). Cumulative 24 h opioid requirements (in morphine equivalents) did not differ between dexmedetomidine [45 mg (30–68 mg)] and control groups [53 mg (38–88 mg)] (<em>P</em>=0.334). More patients in the dexmedetomidine group were satisfied with pain management in the ward (<em>P</em>=0.0013). The groups did not differ in the incidence of postoperative nausea and vomiting (<em>P</em>=0.310) or haemodynamic adverse events (<em>P</em>>0.27 for all).</div></div><div><h3>Conclusions</h3><div>Our results indicate that intranasal dexmedetomidine may reduce postoperative pain and the requirement for additional sedation and increase short-term patient satisfaction in patients undergoing total knee arthroplasty.</div></div><div><h3>Clinical trial registration</h3><div>ClinicalTrials.gov (NCT 04859283).</div></div>\",\"PeriodicalId\":72418,\"journal\":{\"name\":\"BJA open\",\"volume\":\"13 \",\"pages\":\"Article 100382\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BJA open\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2772609625000061\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BJA open","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2772609625000061","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

摘要

先前的研究表明，围手术期使用辅助剂，如α -2激动剂右美托咪定，可以减少术后疼痛和阿片类药物的需求。然而，关于最佳剂量的信息是缺乏的。我们研究了与安慰剂相比，鼻内用药右美托咪定是否能减轻脊柱麻醉下全膝关节置换术患者的术后疼痛。方法本研究是一项单中心、双盲、双臂研究，对101例连续择期行脊柱麻醉下全膝关节置换术的患者，将右美托咪定（单剂量1 μg kg−1）与鼻盐水用药前进行比较。主要结局是术后24小时内用数值评定量表测量的疼痛。次要结局是术后阿片类药物需求、围手术期血流动力学变量、术中额外镇静需求、术后恶心和呕吐发生率以及术后30天的患者满意度。结果右美托咪定组患者3 h的数值评定量表评分[中位数（四分位数间距）2.0(0.0 ~ 3.0)]低于对照组[3.0 (2.0 ~ 4.0)]（P=0.037）。右美托咪定[45 mg (30-68 mg)]和对照组[53 mg (38-88 mg)]之间的累积24小时阿片类药物需取量（吗啡当量）无差异（P=0.334）。右美托咪定组患者对病房疼痛管理满意度较高（P=0.0013）。两组术后恶心呕吐发生率（P=0.310）和血流动力学不良事件发生率（P= 0.27）均无差异。结论右美托咪定鼻内用药可减少全膝关节置换术患者术后疼痛和额外镇静需求，提高患者短期满意度。临床试验注册：clinicaltrials .gov （NCT 04859283）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Premedication with intranasal dexmedetomidine in patients undergoing total knee arthroplasty under spinal anaesthesia (TKADEX)—a prospective, double-blinded, randomised controlled trial

Background

Previous studies have shown that perioperative use of adjuvants, such as the alpha-2 agonist dexmedetomidine, may reduce postoperative pain and opioid requirements. However, information about optimal dosing is lacking. We investigated if premedication with intranasal dexmedetomidine compared with placebo reduces postoperative pain in patients undergoing total knee arthroplasty under spinal anaesthesia.

Methods

This single-centre, double-blind, two-arm study compared premedication with intranasal dexmedetomidine (single 1 μg kg⁻¹ dose) to intranasal saline in 101 consecutive elective patients undergoing total knee arthroplasty under spinal anaesthesia. The primary outcome was postoperative pain measured with the numerical rating scale during the first 24 h. Secondary outcomes were postoperative opioid requirement, perioperative haemodynamic variables, requirement of additional intraoperative sedation, incidence of postoperative nausea and vomiting, and patient satisfaction at 30 days after surgery.

Results

Patients in the dexmedetomidine group had lower numerical rating scale scores [median (interquartile range) 2.0 (0.0–3.0)] at 3 h when compared with the control group [3.0 (2.0–4.0)] (P=0.037). Cumulative 24 h opioid requirements (in morphine equivalents) did not differ between dexmedetomidine [45 mg (30–68 mg)] and control groups [53 mg (38–88 mg)] (P=0.334). More patients in the dexmedetomidine group were satisfied with pain management in the ward (P=0.0013). The groups did not differ in the incidence of postoperative nausea and vomiting (P=0.310) or haemodynamic adverse events (P>0.27 for all).

Conclusions

Our results indicate that intranasal dexmedetomidine may reduce postoperative pain and the requirement for additional sedation and increase short-term patient satisfaction in patients undergoing total knee arthroplasty.