Red Bull Energy Drink Intake After Autologous Microsurgical Breast Reconstruction

Flying High - Exploring the Effect of Red Bull Energy Drink Intake After Autologous Microsurgical Breast Reconstruction

The success rate of autologous microsurgical breast reconstruction depends on adequate intraoperative and postoperative flap perfusion. Perfusion is optimized intraoperatively by a full hyperdynamic circulation and maintenance of a normal body temperature. Additional safe and simple postoperative measures to guarantee adequate perfusion pressure would be desirable. Recently, the effect of Red Bull® Energy Drink on cardiovascular and renal function, pain tolerance as well as performance has been studied in clinical trials involving healthy volunteers and athletes. Notably, an increase in blood pressure, heart rate, improved endothelial function and reduced pain perception have been observed. A better understanding of its effects in patients undergoing autologous microsurgical breast surgery would be of great value. When ingested in standard amounts, Red Bull® Energy Drink has been shown to be a safe beverage without notable side effects. The investigators prospectively study the effect of postoperative oral ingestion of Red Bull® Energy Drink on perfusion-related variables and patient recovery after autologous microsurgical breast reconstruction.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Dietary supplement: Red Bull Energy Drink; Other: Still water

Detailed Description

All consecutive female patients receiving unilateral autologous microsurgical breast reconstruction starting from quarter I 2020 will be administered a total of either 750 ml Red Bull® Energy Drink (intervention group) or 750 ml still water (control group). The first dose of 250 ml Red Bull® Energy Drink or still water will be given 2-3 hours postoperatively. The following doses will be given on postoperative day 1 for breakfast (250 ml) and for lunch (250 ml).

The systolic and diastolic blood pressure as well as pulse will be measured non-invasively using a 24-hour ambulatory blood pressure monitor at regular intervals during the first postoperative 24 hours. Total fluid administered intraoperatively and postoperatively as well as intraoperative and postoperative administration of vasoactive drugs will be recorded. Daily urinary output will be measured during 24 hours after surgery. Pain levels will be measured on Numeric Rating Scale with values ranging from 0 to 10. Rate of operative re-explorations, flap loss and total length of primary hospital stay will be recorded. Wound healing and scarring will be assessed 1 month after surgery in our clinic and documented photographically.

The variables obtained from the intervention group receiving Red Bull® Energy Drink postoperatively will be compared with the corresponding variables of patients in the control group receiving the same amount of still water.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8034
      • Klinik Pyramide am See

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Indication: Patients undergoing unilateral autologous microsurgical breast reconstruction by Prof. Dr. med. Jian Farhadi, Dr. med. Alessia Lardi or Dr. med. Doris Babst
2. Female participants ≥ 18 and ≤ 70 years of age
3. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

1. History of arterial hypertension*
2. History of cardiac rhythm disorder*
3. History of Diabetes mellitus*
4. History of gastric or duodenal ulcer*
5. History of hyperthyroidism or hypothyroidism*
6. Current use of antihypertensive drugs, antiarrhythmic drugs, thyroid hormones (e.g. Euthyrox)*
7. Allergy or intolerance to component of Red Bull® Energy Drink
8. Not fulfilling inclusion criteria. * as diagnosed by the GP in the referral letter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; This group is administered a total of 750 ml Red Bull® Energy Drink at defined time-intervals.	Dietary supplement: Red Bull Energy Drink; The intervention group receives 250 ml Red Bull Energy Drink 2-3 hours after surgery and 500 ml on postoperative day 1. Regimen: 2-3 hours after surgery: 250 ml; Postoperative day 1: morning and noon (1-1-0-0) 250 ml
Placebo Comparator: Placebo group; This group is administered a total of 750 ml still water at defined time-intervals.	Other: Still water; The control group receives 250 ml still water 2-3 hours after surgery and 500 ml on postoperative day 1. Regimen: 2-3 hours after surgery: 250 ml; Postoperative day 1: morning and noon (1-1-0-0) 250 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Difference in mean systolic blood pressure [mmHg] between the intervention group and the control group at 15/30/45/60/75/90/105/120min after each of 3 Red Bull (intervention group)/water (control group) applications	Until 2 hours after last drink ingestion

Collaborators and Investigators

• Sponsor: Plastic Surgery Group AG by Prof. Jian Farhadi
• Investigators: Principal Investigator: Jian Farhadi, M.D., Prof., University of Basel, Plastic Surgery Group AG by Prof. Jian Farhadi, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: May 17, 2020
• First Submitted That Met QC Criteria: May 17, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020-00493 (Other Grant/Funding Number: The Swedish Research Council)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No