Deep versus moderate neuromuscular blockade during total hip arthroplasty to improve postoperative quality of recovery and immune function: protocol for a randomised controlled study

全髋关节置换术中深度神经肌肉阻滞与中度神经肌肉阻滞对改善术后恢复质量和免疫功能的影响:一项随机对照研究方案

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Abstract

INTRODUCTION: There is accumulating evidence that deep neuromuscular blockade (NMB) improves intraoperative surgical conditions during laparoscopic surgery. Studies investigating the effects of deep NMB in open surgery are scarce. In theory, by limiting surgical damage through deeper muscle relaxation, postoperative inflammation and concomitant immune suppression can be reduced. Therefore, this study will investigate the effects of deep NMB during total hip arthroplasty, which demands a relatively large exposure of the hip joint through and in between muscles. METHODS AND ANALYSIS: This study is a monocentre blinded randomised controlled trial in 100 patients undergoing total hip arthroplasty under general anaesthesia. Patients will be randomised in a 1:1 fashion to an intervention group of intraoperative deep NMB (a post-tetanic count of 1-2) or a control group receiving moderate NMB (a train-of-four count of 1-2). NMB will be achieved by continuous or bolus administration of rocuronium, respectively. The primary endpoint is the quality of recovery at postoperative day 1 measured by the Quality of Recovery-40 Questionnaire, analysed by Analysis of Variance. The secondary endpoint is postoperative innate immune function, measured by ex vivo production capacity of tumour necrosis factor and interleukin-1β on endotoxin stimulation of whole blood. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Medical Ethics Committee 'METC Oost-Nederland' (reference number 2022-15754). Informed consent will be obtained prior to study participation. Study results will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov Registry (NCT05562999) and EudraCT Registry (2022-002451-19).

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