High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy

• Status: Completed
• Trial end date: 2018-04-22
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after breast cancer surgery, with removal of the breast (mastectomy). Primary outcome is the proportion patients who require transfer to the post anaesthesia care unit (PACU) and the proportion that can be transferred directly to the ward. Secondary outcomes are organospecific complications in the postanesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first 14 days and readmissions the first 30 days after surgery.

The investigators hypothesize that the frequency of transfer to the PACU and organospecific complications will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections, seroma or readmissions.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• planned unilateral mastectomy with or without axillary dissection or sentinel node in the study period

• informed signed consent

Exclusion Criteria:

• Chronic/ongoing use of glucocorticoids (except inhalation therapy)

• ongoing use of immunosuppressive therapy

• insulin dependent diabetes

• pregnancy/breastfeeding

• allergies toward study medication, or medication in a standard treatment

• contralateral surgery (lumpectomy/mastectomy) at time of mastectomy

• surgery cannot be performed