Phase 4
N=130
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy
Dexamethasone · Glucocorticoids · Mastectomy · Breast Cancer · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03125941 ↗Enrolled (actual)
130
Serious AEs
6.3%
Results posted
Dec 2019
Primary outcome: Primary: Transfer to Post-anesthesia Care Unit (PACU) — 23; 23 Participants — p=1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigshospitalet, Denmark
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transfer to Post-anesthesia Care Unit (PACU) |
23; 23 | 1 |
| SECONDARY Discharge Score,(Modified Aldrete Discharge Score), Operating Room |
0; 1 | 0.114 |
| SECONDARY Discharge Score, Arrival at PACU |
1; 1 | 0.294 |
| SECONDARY Discharge Score, Arrival at Ward |
1; 1 | — |
| SECONDARY Number of Participants With Complication |
12; 9 | — |
| SECONDARY Total Length of Stay in PACU |
1.5; 1.5 | 0.350 |
| SECONDARY Total Length of Stay in Hospital |
9.2; 11 | 0.217 |
| SECONDARY Secondary Transfer |
0; 0 | — |
| SECONDARY Pain, Numeric Rating Scale |
2; 2; 2; 1; 1; 1 | >0.193 |
| SECONDARY Post Operative Nausea and Vomiting (PONV). |
6; 11; 6; 10; 6; 9 | >0.2 |
| SECONDARY Quality of Sleep |
31; 39; 20; 22; 24; 18 | >0.136 |
| SECONDARY Mental Status |
17; 20; 14; 18; 26; 28 | >0.003 |
| SECONDARY Number of Participants With Seroma, Requiring Treatment |
51; 60 | 0.030 sig |
| SECONDARY Readmission |
4; 4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03125941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.