Red Bull Energy Drink Intake After Autologous Microsurgical Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2023-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1 intervention group, 1 placebo group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

This group is administered a total of 750 ml Red Bull® Energy Drink at defined time-intervals.

Group Type EXPERIMENTAL

Red Bull Energy Drink

Intervention Type 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

Placebo group

This group is administered a total of 750 ml still water at defined time-intervals.

Group Type PLACEBO_COMPARATOR

Still water

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No