Comparison of the effects of two concentrations of adrenaline (0.33 mg/l versus 1 mg/l) in the irrigation serum for arthroscopic shoulder surgery: protocol of a randomized controlled trial

Edouard Harly, Anselme Billaud, H. Demezon, Thierry Joudet, Clément Tournier, Antony Pincin
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Abstract

Background: Controlling bleeding during arthroscopic shoulder surgery helps improve the clarity of the arthroscopic visual field. Adrenaline is considered an effective and safe method to reduce bleeding. Two doses of adrenaline (0.33 mg/l and 1 mg/l) have been evaluated in the literature, but never against each other. Methods: This prospective, double-blind, randomized controlled trial will study the clarity of the visual field using a numerical scale (NS) during rotator cuff surgery on 180 patients across 5 centres. The secondary objectives include: the duration of the operation, volume of saline used, increase in baseline pressure, number of arthropump hyperpressures, mean systolic blood pressure and heart rate, as well as sudden variability. Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001). Conclusions: This study aims to determine which of the two dosages previously studied in the literature (0.33 mg/l versus 1 mg/l) provides better clarity. Trial Registration Number: 2021-A02773-38. 
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肩关节镜手术灌洗血清中两种浓度肾上腺素(0.33 毫克/升和 1 毫克/升)的效果比较:随机对照试验方案
背景:在肩关节镜手术中控制出血有助于提高关节镜视野的清晰度。肾上腺素被认为是一种有效而安全的止血方法。文献中对两种剂量的肾上腺素(0.33 毫克/升和 1 毫克/升)进行了评估,但从未相互比较过:这项前瞻性、双盲、随机对照试验将在 5 个中心的 180 名患者中使用数字标度(NS)研究肩袖手术过程中视野的清晰度。次要目标包括:手术持续时间、生理盐水用量、基线压力增加、关节泵超压次数、平均收缩压和心率以及突变性:在临床试验组的154名患者中,70/154(45%)人仍有蛋白尿,84/154(55%)人无蛋白尿(缓解),相比之下,常规护理组有41人(28%)缓解,104人(72%)仍有蛋白尿(P<0.001):本研究旨在确定之前文献中研究的两种剂量(0.33 毫克/升与 1 毫克/升)中哪一种能提供更好的清晰度。
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