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
{"title":"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","authors":"Edouard Harly, Anselme Billaud, H. Demezon, Thierry Joudet, Clément Tournier, Antony Pincin","doi":"10.18203/2349-3259.ijct20240966","DOIUrl":null,"url":null,"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.\nMethods: 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.\nResults: 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).\nConclusions: 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.\nTrial Registration Number: 2021-A02773-38. ","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"55 3","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18203/2349-3259.ijct20240966","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.