Clinical trial NCT03125941: High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dexamethasone
Glucocorticoids
Mastectomy
Breast Cancer
Pain, Postoperative
Nausea and Vomiting, Postoperative
Steroid
Systemic Inflammatory Response Syndrome
Postoperative Complications
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Transfer to Post-anesthesia Care Unit (PACU)
timeFrame: Within 1 hour post-surgery
Secondary outcomes:
measure: Discharge Score,(Modified Aldrete Discharge Score), Operating Room
timeFrame: At transfer from operating room, within 1 hour post-surgery
measure: Discharge Score, Arrival at PACU
timeFrame: within 3 hours
measure: Discharge Score, Arrival at Ward
timeFrame: within 3 hours
measure: Number of Participants With Complication
timeFrame: 24 hours
measure: Total Length of Stay in PACU
timeFrame: 12 hours
measure: Total Length of Stay in Hospital
timeFrame: 24-48 hours
measure: Secondary Transfer
timeFrame: 24-48 hours
measure: Pain, Numeric Rating Scale
timeFrame: days 0-4
measure: Post Operative Nausea and Vomiting (PONV).
timeFrame: days 0-4
measure: Quality of Sleep
timeFrame: days 0-4
measure: Mental Status
timeFrame: days 0-4
measure: Number of Participants With Seroma, Requiring Treatment
timeFrame: 14 days
measure: Readmission
timeFrame: 30 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kristin J Steinthorsdottir, MD
role: PRINCIPAL_INVESTIGATOR
References: