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Completed

NCT Number: NCT04397419

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Pyramide am See

Zurich, Canton of Zurich, 8034, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication: Patients undergoing unilateral autologous microsurgical breast reconstruction by Prof. Dr. med. Jian Farhadi, Dr. med. Alessia Lardi or Dr. med. Doris Babst
  • Female participants ≥ 18 and ≤ 70 years of age
  • 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

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

Treatment and study plan

Red Bull Energy Drink

Dietary Supplement

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

Still water

Other

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

Primary outcomes

  1. Blood pressure

    Time frame: Until 2 hours after last drink ingestion

    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

Sponsors and collaborators

Lead sponsor

Plastic Surgery Group AG by Prof. Jian Farhadi

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 21, 2020
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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