Red Bull Energy Drink Intake After Autologous Microsurgical Breast Reconstruction
Condition: Breast Cancer
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Red Bull Energy Drink; Still water
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1 intervention group, 1 placebo group
Masking: None (Open Label)
Primary purpose: Treatment