Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 1, 2022
Date Accepted: Apr 12, 2023
Exploring the Effect of Red Bull® Energy Drink after Microsurgical Breast Reconstruction in a Randomized Controlled Trial: Study Protocol and Analysis Plan
ABSTRACT
Background:
Maintaining a sufficiently high postoperative systolic blood pressure is vital for flap perfusion after microsurgical breast reconstruction. Yet, many women undergoing these procedures have a low postoperative systolic blood pressure. Intravenous volume administration or vasopressors may be needed to maintain systolic blood pressure above a pre-defined threshold. However, these measures may provoke volume overload and flap stasis, and the postoperative use of vasopressors may be limited depending on institutional standards. Evidence suggests that Red Bull® Energy drink could potentially have a similar effect by increasing blood pressure.
Objective:
The primary objective of this study is to determine the difference in systolic blood pressure between the intervention group and the control group at predefined intervals after each of three Red Bull® or still water ingestions. Secondary objectives include postoperative heart rate, 24-hour-fluid balance, pain level, or necessity for revision surgery due to flap complications.
Methods:
The Red Bull® study is a prospective, multi-center, randomized controlled trial comparing the effect of postoperative ingestion of Red Bull® Energy drink at predefined intervals against still water in patients undergoing microsurgical breast reconstruction.
Results:
This article describes the Red Bull® study trial protocol and analysis plan.
Conclusions:
The information will increase the transparency of the data analysis for the Red Bull® study. Clinical Trial: ClinicalTrials.gov and KEK-ZH protocol record 2020-00493. Registered 17 May 2020.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.