CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 130 enrolled
Drug / intervention
Dexamethasonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03125941
NCT03125941Phase 4Completed

Effect of High vs Low Dose Intravenous Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy- a Randomized, Double-blind, Controlled Trial

Rigshospitalet, Denmark·interventional·Posted Apr 24, 2017·Updated Dec 2, 2019

In Brief

A Phase 4 clinical trial evaluating Dexamethasone for Dexamethasone and 8 related conditions. Completed, enrolled 130 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 24, 2017
Enrollment StartMar 27, 2017
Primary CompletionApr 22, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.2 years ago

Interventions

Dexamethasonedrug

pre-operative intravenous administration