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脊髓麻醉下全膝关节置换术患者鼻内给予右美托咪定进行术前用药(TKADEX)——一项前瞻性、双盲、随机对照试验。

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

作者信息

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

机构信息

Department of Anaesthesiology and Intensive Care, University of Turku, Turku, Finland.

Division of Perioperative Services, Intensive Care and Pain Medicine, Turku University Hospital, Turku, Finland.

出版信息

BJA Open. 2025 Mar 3;13:100382. doi: 10.1016/j.bjao.2025.100382. eCollection 2025 Mar.

DOI:10.1016/j.bjao.2025.100382
PMID:40114985
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11923756/
Abstract

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 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)] (=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)] (=0.334). More patients in the dexmedetomidine group were satisfied with pain management in the ward (=0.0013). The groups did not differ in the incidence of postoperative nausea and vomiting (=0.310) or haemodynamic adverse events (>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.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov (NCT04859283).

摘要

背景

先前的研究表明,围手术期使用佐剂,如α-2激动剂右美托咪定,可能会减轻术后疼痛并减少阿片类药物的用量。然而,关于最佳剂量的信息尚缺。我们研究了在脊髓麻醉下行全膝关节置换术的患者中,与安慰剂相比,鼻内给予右美托咪定进行术前用药是否能减轻术后疼痛。

方法

这项单中心、双盲、双臂研究将101例连续接受脊髓麻醉下行全膝关节置换术的择期患者分为两组,一组接受鼻内右美托咪定(单次1 μg/kg剂量)术前用药,另一组接受鼻内生理盐水术前用药。主要结局是术后24小时内用数字评定量表测量的术后疼痛。次要结局包括术后阿片类药物用量、围手术期血流动力学变量、术中额外镇静的需求、术后恶心呕吐的发生率以及术后30天的患者满意度。

结果

与对照组[3.0(2.0 - 4.0)]相比,右美托咪定组患者在术后3小时的数字评定量表评分更低[中位数(四分位间距)2.0(0.0 - 3.0)](P = 0.037)。右美托咪定组[45 mg(30 - 68 mg)]和对照组[53 mg(38 - 88 mg)]的24小时累计阿片类药物用量无差异(P = 0.334)。右美托咪定组更多患者对病房内的疼痛管理感到满意(P = 0.0013)。两组在术后恶心呕吐发生率(P = 0.310)或血流动力学不良事件方面(所有事件P均>0.27)无差异。

结论

我们的结果表明,鼻内给予右美托咪定可能会减轻全膝关节置换术患者的术后疼痛以及对额外镇静的需求,并提高患者短期满意度。

临床试验注册

ClinicalTrials.gov(NCT04859283)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d3/11923756/c67e4aa29a54/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d3/11923756/2594bafb89f7/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d3/11923756/c5f7ffee5ee7/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d3/11923756/c67e4aa29a54/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d3/11923756/2594bafb89f7/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d3/11923756/c5f7ffee5ee7/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/65d3/11923756/c67e4aa29a54/gr3.jpg

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