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Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial

BACKGROUND: Maintaining a sufficiently high systolic blood pressure is essential for free flap perfusion after microsurgical breast reconstruction. Yet, many women undergoing these procedures have low postoperative systolic blood pressure. Intravenous volume administration or vasopressors may be nee...

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Autores principales: Speck, Nicole Edith, Michalak, Michal, Dreier, Kathrin, Babst, Doris, Lardi, Alessia Marisa, Farhadi, Jian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10206609/
https://www.ncbi.nlm.nih.gov/pubmed/37159251
http://dx.doi.org/10.2196/38487
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author Speck, Nicole Edith
Michalak, Michal
Dreier, Kathrin
Babst, Doris
Lardi, Alessia Marisa
Farhadi, Jian
author_facet Speck, Nicole Edith
Michalak, Michal
Dreier, Kathrin
Babst, Doris
Lardi, Alessia Marisa
Farhadi, Jian
author_sort Speck, Nicole Edith
collection PubMed
description BACKGROUND: Maintaining a sufficiently high systolic blood pressure is essential for free flap perfusion after microsurgical breast reconstruction. Yet, many women undergoing these procedures have low postoperative systolic blood pressure. Intravenous volume administration or vasopressors may be needed to maintain systolic blood pressure above a predefined threshold. However, excessive volume administration may lead to volume overload and flap stasis, and the postoperative use of vasopressors may be limited depending on institutional standards. Additional nonpharmacological measures to raise blood pressure might be beneficial. Evidence suggests that the Red Bull energy drink could raise blood pressure. It has been shown to increase systolic and diastolic blood pressure in healthy volunteers and athletes. OBJECTIVE: The primary objective of this study is to determine the difference in systolic blood pressure between an intervention group receiving Red Bull and a control group receiving still water after microsurgical breast reconstruction. 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, multicenter randomized controlled trial comparing the effect of postoperative ingestion of Red Bull energy drink against still water in female patients undergoing unilateral microsurgical breast reconstruction. A total of 250 mL of Red Bull (intervention group) or 250 mL of still water (control group) will be administered to the study participants 2 hours postoperatively as well as for breakfast and lunch on postoperative day 1, amounting to a total volume of 750 mL per 24 hours. Female patients between 18 and 70 years of age undergoing unilateral microsurgical breast reconstruction will be included. Exclusion criteria are a history of arterial hypertension, cardiac rhythm disorder, diabetes mellitus, gastric or duodenal ulcer, thyroid disease, and current use of antihypertensive or antiarrhythmic drugs or thyroid hormones, as well as intolerance to Red Bull. RESULTS: Recruitment for the study started in June 2020 and was completed in December 2022. There is evidence that the Red Bull energy drink increases blood pressure in healthy volunteers and athletes. We hypothesize that postoperative ingestion of Red Bull will increase systolic blood pressure in women after microsurgical breast reconstruction. Red Bull could hence be used as a nonpharmacological adjunct to vasopressors or volume administration in women with hypotensive blood pressure after microsurgical breast reconstruction. CONCLUSIONS: This paper describes the Red Bull study trial protocol and analysis plan. The information will increase the transparency of the data analysis for the Red Bull study. TRIAL REGISTRATION: ClinicalTrials.gov NCT04397419; https://clinicaltrials.gov/ct2/show/NCT04397419 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38487
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spelling pubmed-102066092023-05-25 Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial Speck, Nicole Edith Michalak, Michal Dreier, Kathrin Babst, Doris Lardi, Alessia Marisa Farhadi, Jian JMIR Res Protoc Protocol BACKGROUND: Maintaining a sufficiently high systolic blood pressure is essential for free flap perfusion after microsurgical breast reconstruction. Yet, many women undergoing these procedures have low postoperative systolic blood pressure. Intravenous volume administration or vasopressors may be needed to maintain systolic blood pressure above a predefined threshold. However, excessive volume administration may lead to volume overload and flap stasis, and the postoperative use of vasopressors may be limited depending on institutional standards. Additional nonpharmacological measures to raise blood pressure might be beneficial. Evidence suggests that the Red Bull energy drink could raise blood pressure. It has been shown to increase systolic and diastolic blood pressure in healthy volunteers and athletes. OBJECTIVE: The primary objective of this study is to determine the difference in systolic blood pressure between an intervention group receiving Red Bull and a control group receiving still water after microsurgical breast reconstruction. 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, multicenter randomized controlled trial comparing the effect of postoperative ingestion of Red Bull energy drink against still water in female patients undergoing unilateral microsurgical breast reconstruction. A total of 250 mL of Red Bull (intervention group) or 250 mL of still water (control group) will be administered to the study participants 2 hours postoperatively as well as for breakfast and lunch on postoperative day 1, amounting to a total volume of 750 mL per 24 hours. Female patients between 18 and 70 years of age undergoing unilateral microsurgical breast reconstruction will be included. Exclusion criteria are a history of arterial hypertension, cardiac rhythm disorder, diabetes mellitus, gastric or duodenal ulcer, thyroid disease, and current use of antihypertensive or antiarrhythmic drugs or thyroid hormones, as well as intolerance to Red Bull. RESULTS: Recruitment for the study started in June 2020 and was completed in December 2022. There is evidence that the Red Bull energy drink increases blood pressure in healthy volunteers and athletes. We hypothesize that postoperative ingestion of Red Bull will increase systolic blood pressure in women after microsurgical breast reconstruction. Red Bull could hence be used as a nonpharmacological adjunct to vasopressors or volume administration in women with hypotensive blood pressure after microsurgical breast reconstruction. CONCLUSIONS: This paper describes the Red Bull study trial protocol and analysis plan. The information will increase the transparency of the data analysis for the Red Bull study. TRIAL REGISTRATION: ClinicalTrials.gov NCT04397419; https://clinicaltrials.gov/ct2/show/NCT04397419 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38487 JMIR Publications 2023-05-09 /pmc/articles/PMC10206609/ /pubmed/37159251 http://dx.doi.org/10.2196/38487 Text en ©Nicole Edith Speck, Michal Michalak, Kathrin Dreier, Doris Babst, Alessia Marisa Lardi, Jian Farhadi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.05.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Speck, Nicole Edith
Michalak, Michal
Dreier, Kathrin
Babst, Doris
Lardi, Alessia Marisa
Farhadi, Jian
Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial
title Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial
title_full Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial
title_fullStr Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial
title_full_unstemmed Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial
title_short Effect of the Red Bull Energy Drink on Perfusion-Related Variables in Women Undergoing Microsurgical Breast Reconstruction: Protocol and Analysis Plan for a Prospective, Multicenter Randomized Controlled Trial
title_sort effect of the red bull energy drink on perfusion-related variables in women undergoing microsurgical breast reconstruction: protocol and analysis plan for a prospective, multicenter randomized controlled trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10206609/
https://www.ncbi.nlm.nih.gov/pubmed/37159251
http://dx.doi.org/10.2196/38487
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