DEX-MAS: High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT03125941
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.8
• Patients Per Site Per Month: 10.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dexamethasone; Glucocorticoids; Mastectomy; Breast Cancer; Pain, Postoperative; Nausea and Vomiting, Postoperative; Steroid; Systemic Inflammatory Response Syndrome; Postoperative Complications	Drug: Dexamethasone	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 27, 2017
• Actual Primary Completion Date: Apr 22, 2018
• Actual Study Completion Date: Apr 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexamethasone 8 mg Dexamethasone 8 mg pre-operative	Drug: Dexamethasone; pre-operative intravenous administration
Active Comparator: Dexamethasone 24 mg Dexamethasone 24 mg pre-operative	Drug: Dexamethasone; pre-operative intravenous administration

Outcome Measures

Primary Outcome Measures

1. Transfer to Post-anesthesia Care Unit (PACU) [Within 1 hour post-surgery]

   Number of patients meeting criteria for transfer to PACU post-surgery

Secondary Outcome Measures

1. Discharge Score,(Modified Aldrete Discharge Score), Operating Room [At transfer from operating room, within 1 hour post-surgery]

   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.

2. Discharge Score, Arrival at PACU [within 3 hours]

   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.

3. Discharge Score, Arrival at Ward [within 3 hours]

   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.

4. Number of Participants With Complication [24 hours]

   complications requiring treatment until discharge

5. Total Length of Stay in PACU [12 hours]

   Length of stay in the post-anesthesia care unit (PACU), measured as hours and minutes, from start of procedure, to discharge from PACU

6. Total Length of Stay in Hospital [24-48 hours]

   Length of stay in hospital, measured from start of procedure to discharge from hospital to home

7. Secondary Transfer [24-48 hours]

   Secondary transfer to PACU from ward, or to intensive care unit from PACU

8. Pain, Numeric Rating Scale [days 0-4]

   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.

9. Post Operative Nausea and Vomiting (PONV). [days 0-4]

   Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting

10. Quality of Sleep [days 0-4]

    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

11. Mental Status [days 0-4]

    Self-reported feelings of restlessness, sadness and fatigue (days 0-4). Questionnaire (anwers possible: yes or no. Numbers are patients answering yes)

12. Number of Participants With Seroma, Requiring Treatment [14 days]

    Seroma, requiring treatment the first 14 days.

13. Readmission [30 days]

    Any readmission, days 0-30

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

• Principal Investigator: Kristin J Steinthorsdottir, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 16, 2018

More Information

Publications

None provided.

• Responsible Party: Kristin Julia Steinthorsdottir, Principal investigator, MD, Clinical assistant, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT03125941
• Other Study ID Numbers: DEXMAS01; 2017-000227-27
• First Posted: Apr 24, 2017
• Last Update Posted: Dec 2, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vomiting; Pain, Postoperative; Postoperative Complications; Systemic Inflammatory Response Syndrome; Postoperative Nausea and Vomiting; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Period Title: Overall Study
STARTED	65	65
Post-randomization Exclusion	1	2
COMPLETED	64	63
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg	Total
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration	Total of all reporting groups
Overall Participants	65	65	130
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	66	63	65
Sex: Female, Male (Count of Participants)
Female	63 96.9%	65 100%	128 98.5%
Male	2 3.1%	0 0%	2 1.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

primary outcome was per intention to treat, secondary outcomes were per protocol (we had 3 post-randomization exclusions, that did not receive the intervention)

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	65	65
Count of Participants [Participants]	23 35.4%	23 35.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.49 to 2.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	63	64
Median (Inter-Quartile Range) [score on a scale]	0	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.114
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	63	64
Median (Inter-Quartile Range) [score on a scale]	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.294
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	63	64
Median (Inter-Quartile Range) [score on a scale]	1	1

5. Secondary Outcome

Title	Number of Participants With Complication
Description	complications requiring treatment until discharge
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	63	64
Count of Participants [Participants]	12 18.5%	9 13.8%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	12	12
Median (Inter-Quartile Range) [hours]	1.5	1.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.350
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	63	64
Median (Inter-Quartile Range) [hours]	9.2	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.217
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Secondary Transfer
Description	Secondary transfer to PACU from ward, or to intensive care unit from PACU
Time Frame	24-48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	63	64
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	52	56
Day 0, average	2	2
Day 1, average	2	1
Day 2, average	1	1
Day 3, average	1	1
Day 4, average	1	1
Day 0, worst	3	3
Day 1, worst	2	1.5
Day 2, worst	2	2
Day 3, worst	1	1
Day 4, worst	1	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.193
	Comments	a priori threshold, bonferroni corrected 0.0125
	Method	Wilcoxon (Mann-Whitney)
	Comments

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	52	56
DAY 0	6 9.2%	11 16.9%
DAY 1	6 9.2%	10 15.4%
DAY 2	6 9.2%	9 13.8%
DAY 3	7 10.8%	6 9.2%
DAY 4	7 10.8%	6 9.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.2
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	52	56
DAY 0	31 47.7%	39 60%
DAY 1	20 30.8%	22 33.8%
DAY 2	24 36.9%	18 27.7%
DAY 3	18 27.7%	17 26.2%
DAY 4	17 26.2%	16 24.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.136
	Comments
	Method	Chi-squared
	Comments

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	52	56
DAY 0 : restlessness	17 26.2%	20 30.8%
DAY 0 : sadness	14 21.5%	18 27.7%
DAY 0 : fatigue	26 40%	28 43.1%
DAY 1 : restlessness	9 13.8%	9 13.8%
DAY 1 : sadness	13 20%	13 20%
DAY 1 : fatigue	11 16.9%	27 41.5%
DAY 2 : restlessness	14 21.5%	8 12.3%
DAY 2 : sadness	14 21.5%	18 27.7%
DAY 2 : fatigue	16 24.6%	17 26.2%
DAY 3 : restlessness	11 16.9%	8 12.3%
DAY 3 : sadness	14 21.5%	20 30.8%
DAY 3 : fatigue	14 21.5%	17 26.2%
DAY 4 : restlessness	13 20%	13 20%
DAY 4 : sadness	14 21.5%	12 18.5%
DAY 4 : fatigue	14 21.5%	15 23.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.003
	Comments	A priori threshold for statistical significans was 0.00125 due to multiple comparisons
	Method	Chi-squared
	Comments

13. Secondary Outcome

Title	Number of Participants With Seroma, Requiring Treatment
Description	Seroma, requiring treatment the first 14 days.
Time Frame	14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	63	64
Count of Participants [Participants]	51 78.5%	60 92.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 8 mg, Dexamethasone 24 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.030
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.53
	Confidence Interval	(2-Sided) 95%; 1.07 to 11.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Readmission
Description	Any readmission, days 0-30
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 8 mg	Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Measure Participants	63	64
Count of Participants [Participants]	4 6.2%	4 6.2%

Adverse Events

Time Frame	60 hours from administration of study drug
Adverse Event Reporting Description	Adverse events are collected from patients that received the study drug (63 and 64 in the 8 and 24 mg group respectively), we had 3 post-randomization exclusion, they did not receive the study drug and adverse events were not collected in agreement with the Good Clinical Practise (GCP) monitor
Arm/Group Title	Dexamethasone 8 mg		Dexamethasone 24 mg
Arm/Group Description	Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration		Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
All Cause Mortality
	Dexamethasone 8 mg		Dexamethasone 24 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/64 (0%)
Serious Adverse Events
	Dexamethasone 8 mg		Dexamethasone 24 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/63 (7.9%)		3/64 (4.7%)
Surgical and medical procedures
wound hemorrhage	5/63 (7.9%)	5	3/64 (4.7%)	3
Other (Not Including Serious) Adverse Events
	Dexamethasone 8 mg		Dexamethasone 24 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/64 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.