High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy (DEX-MAS)
Primary Purpose
Dexamethasone, Glucocorticoids, Mastectomy
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Dexamethasone
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
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexamethasone 8 mg
Dexamethasone 24 mg
Arm Description
Dexamethasone 8 mg pre-operative
Dexamethasone 24 mg pre-operative
Outcomes
Primary Outcome Measures
Transfer to Post-anesthesia Care Unit (PACU)
Number of patients meeting criteria for transfer to PACU post-surgery
Secondary Outcome Measures
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.
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.
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.
Number of Participants With Complication
complications requiring treatment until discharge
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
Total Length of Stay in Hospital
Length of stay in hospital, measured from start of procedure to discharge from hospital to home
Secondary Transfer
Secondary transfer to PACU from ward, or to intensive care unit from PACU
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.
Post Operative Nausea and Vomiting (PONV).
Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting
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
Mental Status
Self-reported feelings of restlessness, sadness and fatigue (days 0-4). Questionnaire (anwers possible: yes or no. Numbers are patients answering yes)
Number of Participants With Seroma, Requiring Treatment
Seroma, requiring treatment the first 14 days.
Readmission
Any readmission, days 0-30
Full Information
NCT ID
NCT03125941
First Posted
March 28, 2017
Last Updated
November 27, 2019
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03125941
Brief Title
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy
Acronym
DEX-MAS
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
April 22, 2018 (Actual)
Study Completion Date
April 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexamethasone, Glucocorticoids, Mastectomy, Breast Cancer, Pain, Postoperative, Nausea and Vomiting, Postoperative, Steroid, Systemic Inflammatory Response Syndrome, Postoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone 8 mg
Arm Type
Active Comparator
Arm Description
Dexamethasone 8 mg pre-operative
Arm Title
Dexamethasone 24 mg
Arm Type
Active Comparator
Arm Description
Dexamethasone 24 mg pre-operative
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
pre-operative intravenous administration
Primary Outcome Measure Information:
Title
Transfer to Post-anesthesia Care Unit (PACU)
Description
Number of patients meeting criteria for transfer to PACU post-surgery
Time Frame
Within 1 hour post-surgery
Secondary Outcome Measure Information:
Title
Discharge Score,(Modified Aldrete Discharge Score), Operating Room
Description
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.
Time Frame
At transfer from operating room, within 1 hour post-surgery
Title
Discharge Score, Arrival at PACU
Description
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.
Time Frame
within 3 hours
Title
Discharge Score, Arrival at Ward
Description
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.
Time Frame
within 3 hours
Title
Number of Participants With Complication
Description
complications requiring treatment until discharge
Time Frame
24 hours
Title
Total Length of Stay in PACU
Description
Length of stay in the post-anesthesia care unit (PACU), measured as hours and minutes, from start of procedure, to discharge from PACU
Time Frame
12 hours
Title
Total Length of Stay in Hospital
Description
Length of stay in hospital, measured from start of procedure to discharge from hospital to home
Time Frame
24-48 hours
Title
Secondary Transfer
Description
Secondary transfer to PACU from ward, or to intensive care unit from PACU
Time Frame
24-48 hours
Title
Pain, Numeric Rating Scale
Description
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.
Time Frame
days 0-4
Title
Post Operative Nausea and Vomiting (PONV).
Description
Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting
Time Frame
days 0-4
Title
Quality of Sleep
Description
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
Time Frame
days 0-4
Title
Mental Status
Description
Self-reported feelings of restlessness, sadness and fatigue (days 0-4). Questionnaire (anwers possible: yes or no. Numbers are patients answering yes)
Time Frame
days 0-4
Title
Number of Participants With Seroma, Requiring Treatment
Description
Seroma, requiring treatment the first 14 days.
Time Frame
14 days
Title
Readmission
Description
Any readmission, days 0-30
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin J Steinthorsdottir, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not planned to share IPD
Learn more about this trial
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy
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