Breast Cancer Clinical Trial
Official title:
Effect of High vs Low Dose Intravenous Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy- a Randomized, Double-blind, Controlled Trial
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.
Post-surgery, patients are traditionally observed and treated in post-anesthesia care units
(PACU) until they are discharged to the ward (or directly home) assessed by standardized
international discharge criteria.
The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of
2016 systematically collected and analyzed procedure-related complications in the recovery
phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems,
orthostatic intolerance and cognitive disorders. Common to all the above-mentioned
post-operative problems are the possible links to the inflammatory response caused by the
surgical trauma.
Glucocorticoids can in this context be central for the reduction of acute postoperative organ
dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical
procedures, single dose, pre-operative glucocorticoids have been shown to reduce
post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as
accelerate the convalescence.
Meta-analyses also showed that single-dose administration of glucocorticoids
(methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term
treatment.
Based on positive results in other procedure-specific studies, all mastectomy patients at
Rigshospitalet, have received pre-operative high-dose steroids, in the form of 24 mg
dexamethasone injection since mid-2015. This has resulted in a decrease in the proportion of
patients who need observation in PACU from 30 % to 10 %. The reduction is primarily due to
less pain, less sedation, and lower opioid administration.
Whether this is also partly due to a "systemic effect" (Hawthorn effect) as a result of
increased focus on the area cannot be excluded.
Prior to creating clinical recommendations and standards, it is required that the results be
tested in a randomized, controlled, clinical trial.
The study is not placebo-controlled since the positive effects of dexamethasone 8 mg on PONV
have been shown in numerous trials, and is already being administered to all patients at the
clinic. It would therefore not be ethically correct to withdraw from this practise.
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