Breast Cancer Clinical Trial
— DEX-MASOfficial title:
Effect of High vs Low Dose Intravenous Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy- a Randomized, Double-blind, Controlled Trial
Verified date | November 2019 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | April 22, 2018 |
Est. primary completion date | April 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transfer to Post-anesthesia Care Unit (PACU) | Number of patients meeting criteria for transfer to PACU post-surgery | Within 1 hour post-surgery | |
Secondary | Discharge Score,(Modified Aldrete Discharge Score), Operating Room | Danish Society of Anesthesiology and Intensive Care Medicine (DASAIM) discharge score.Construct: The score consists of six modalities (subscores): Sedation,Oxygen saturation,blood pressure,heart rate,pain (at rest)and nausea.Each modality has a score between 0 and 3,and patients are considered dischargeable to the ward when the score sum of all criteria (total score) is 4 or less and no single score is above 1. All values (subscores) are considered best at 0 and worst at 3. Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping aroused by physical stimuli, 3 sleeping cannot be aroused. Oxygen saturation (%):0 =94, 1 90-93, 2 85-89, 3 <85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or >220, 3<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 <40 or >130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 = 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting. |
At transfer from operating room, within 1 hour post-surgery | |
Secondary | Discharge Score, Arrival at PACU | DASAIM score (Danish Society of Anesthesiology and Intensive Care Medicine). The score consists of six modalities: Sedation, Oxygen saturation, blood pressure, heart rate, pain (at rest) and nausea. Each modality has a score between 0 and 3, and patients are considered dischargeable to the ward when the score sum of all criteria is four or less and no single score is above one. Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping, aroused by physical stimuli, 3 sleeping, cannot be aroused. Oxygen saturation (%): 0 = 94, 1 90-93, 2 85-89, 3 <85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or >220, 3<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 <40 or >130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 = 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting. |
within 3 hours | |
Secondary | Discharge Score, Arrival at Ward | DASAIM score (Danish Society of Anesthesiology and Intensive Care Medicine). The score consists of six modalities: Sedation, Oxygen saturation, blood pressure, heart rate, pain (at rest) and nausea. Each modality has a score between 0 and 3, and patients are considered dischargeable to the ward when the score sum of all criteria is four or less and no single score is above one. Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping, aroused by physical stimuli, 3 sleeping, cannot be aroused. Oxygen saturation (%): 0 = 94, 1 90-93, 2 85-89, 3 <85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or >220, 3<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 <40 or >130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 = 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting. |
within 3 hours | |
Secondary | Number of Participants With Complication | complications requiring treatment until discharge | 24 hours | |
Secondary | Total Length of Stay in PACU | Length of stay in the post-anesthesia care unit (PACU), measured as hours and minutes, from start of procedure, to discharge from PACU | 12 hours | |
Secondary | Total Length of Stay in Hospital | Length of stay in hospital, measured from start of procedure to discharge from hospital to home | 24-48 hours | |
Secondary | Secondary Transfer | Secondary transfer to PACU from ward, or to intensive care unit from PACU | 24-48 hours | |
Secondary | Pain, Numeric Rating Scale | Self-reported pain (worst and average (average through that day), days 0-4) on a numeric rating scale (NRS) 0-10. 0 is no pain, 10 is worst pain imaginable.. Questionnaire. | days 0-4 | |
Secondary | Post Operative Nausea and Vomiting (PONV). | Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting | days 0-4 | |
Secondary | Quality of Sleep | Self-reported quality of sleep (days 0-4). Questionnaire. Dichotomized to Good sleep or sleep problems, numbers reported are number of patients with sleep problems | days 0-4 | |
Secondary | Mental Status | Self-reported feelings of restlessness, sadness and fatigue (days 0-4). Questionnaire (anwers possible: yes or no. Numbers are patients answering yes) | days 0-4 | |
Secondary | Number of Participants With Seroma, Requiring Treatment | Seroma, requiring treatment the first 14 days. | 14 days | |
Secondary | Readmission | Any readmission, days 0-30 | 30 days |
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