DEX-GANZ: High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT03161938
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 27.9
• Patients Per Site Per Month: 2.3

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 periacetabular osteotomy. Primary outcome is the proportion of patients who have moderate to severe postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific complications in the post anaesthesia phase, pain and nausea the first 5 days, wound infection and readmissions the first 30 days after surgery.

The investigators hypothesize that the frequency of moderate to severe pain and organspecific complications in the post anaesthesia care unit will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections or readmissions.

Condition or Disease	Intervention/Treatment	Phase
Hip Dysplasia; 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.

The "Why in PACU?" database shows that 70 % of patients experience moderate to severe pain in the immediate postoperative phase. This is despite a multimodal analgesic regime with preoperative analgesics and local analgesic catheter in the surgical site.

Opioids are frequently administered to relieve pain, resulting in sedation, risk of hypoxia and delaying mobilization.

Patients having Ganz osteotomy are primarily young women with hipdysplasia, that are otherwise healthy. Lenght of stay is typically 5 days, due to pain and lack of mobilisation.

In this study patients are randomized to either high dose (48 mg) or standard/low dose (8 mg) dexamethasone, administered preoperatively. The hypothese is that patients receiving high dose dexamethasone will experience less pain in the immediate postoperative course and receive less opioids.

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: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Periacetabular (GANZ) Osteotomy
• Actual Study Start Date: Apr 24, 2017
• Actual Primary Completion Date: Aug 20, 2019
• Actual Study Completion Date: Aug 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexamethasone 48 mg Dexamethasone 48 mg pre-operative, single shot injection	Drug: Dexamethasone; intravenous
Active Comparator: Dexamethasone 8 mg Dexamethasone 8 mg pre-operative, single shot injection	Drug: Dexamethasone; intravenous

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Moderate to Severe Postoperative Pain [12 hours]

   Moderate to severe pain (NRS > 3) in the post-anesthesia care unit (PACU)

Secondary Outcome Measures

1. Lenght of Stay, PACU [24 hours]

   Total lenght of stay in PACU

2. Lenght of Stay, Hospital [1 week]

   Total lenght of stay, Hospital

3. Pain Scores, PACU [12 hours]

   Differences between groups in maximal and average pain score during PACU stay. Pain scores are measured on a numeric rating scale (NRS), 0-10. 0 is no pain, 10 is worst pain imaginable.

4. Complications [24 hours]

   Patients with complications requiring treatment the first 24 hours (PACU and ward)

5. Self Reported Postoperative Pain [postoperative day 0 to 4, once a day]

   Self-reported pain on a Numeric rating scale (NRS), NRS 0-10, 0 = no pain, 10= worst pain imaginable. Reported once daily, postoperative days 0 to 4

6. Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4 [postoperative day 0 to 4, once a day]

   Patients reporting PONV and/or receiving antiemetic medication on postoperative days 0 to 4

7. Number of Patients With Sleep Problems [4 days]

   Self-reported quality of sleep (days 0-4). Questionnaire. Results dichotomized to sleep problems (trouble falling asleep, frequent awakenings, no sleep) or no sleep problems.

8. Number of Patients With Feelings of Anxiety, Unrest and/or Sadness [postoperative day 0 to 4, once a day]

   Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire

9. Number of Patients Readmitted to Hospital Within 30 Days [30 days]

   Any readmission within 30 days

10. Number of Patients With Wound Infections Within 30 Days [30 days]

    Any wound infections/complications

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• planned unilateral periacetabular osteotomy

• informed signed consent

Exclusion Criteria:

• Chronic/ongoing (<30 days) use of glucocorticoids (except inhalation therapy)

• ongoing (<30 days) use of immunosuppressive therapy

• insulin dependent diabetes

• pregnancy/breastfeeding

• allergies toward study medication, or medication in the standard treatment

• 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)

• Statistical Analysis Plan - May 16, 2018
• Study Protocol - Mar 6, 2017

More Information

Publications

None provided.

• Responsible Party: Kristin Julia Steinthorsdottir, MD, clinical assistant, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT03161938
• Other Study ID Numbers: DEXGANZ01
• First Posted: May 22, 2017
• Last Update Posted: Apr 29, 2020
• Last Verified: Apr 1, 2020

• 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
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Postoperative Complications; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Period Title: Overall Study
STARTED	32	32
COMPLETED	32	32
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg	Total
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous	Total of all reporting groups
Overall Participants	32	32	64
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28 (8)	29 (7)	29 (8)
Sex: Female, Male (Count of Participants)
Female	27 84.4%	24 75%	51 79.7%
Male	5 15.6%	8 25%	13 20.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23 (3)	23 (3)	23 (3)
Previous operation (contralateral periacetabular osteotomy) (Count of Participants)
Count of Participants [Participants]	3 9.4%	9 28.1%	12 18.8%
Comorbidities, none (Count of Participants)
Count of Participants [Participants]	30 93.8%	27 84.4%	57 89.1%
Daily intake of analgesics, preoperative (Count of Participants)
Count of Participants [Participants]	4 12.5%	6 18.8%	10 15.6%
Daily intake of opioids, preoperative (Count of Participants)
Count of Participants [Participants]	2 6.3%	2 6.3%	4 6.3%
Operating time (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	71 (20)	69 (13)	70 (17)
Bleeding (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	467 (301)	510 (295)	500 (296)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Moderate to Severe Postoperative Pain
Description	Moderate to severe pain (NRS > 3) in the post-anesthesia care unit (PACU)
Time Frame	12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	32	32
Count of Participants [Participants]	26 81.3%	22 68.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Null hypothesis: Patients receiving 48 mg of preoperative dexamethasone have less postoperative pain. Power calculation: Acute pain is reduced from 70% to 35% for patients receiving 48 mg of dexamathesone, 80% power, 0.05 statistical significance level.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.248
	Comments
	Method	Chi-squared, Corrected
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.508
	Confidence Interval	(2-Sided) 95%; 0.159 to 1.620
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Lenght of Stay, PACU
Description	Total lenght of stay in PACU
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	32	32
Median (Inter-Quartile Range) [hours]	2	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.519
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Lenght of Stay, Hospital
Description	Total lenght of stay, Hospital
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	32	32
Median (Inter-Quartile Range) [hours]	78	77

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.468
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Pain Scores, PACU
Description	Differences between groups in maximal and average pain score during PACU stay. Pain scores are measured on a numeric rating scale (NRS), 0-10. 0 is no pain, 10 is worst pain imaginable.
Time Frame	12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	32	32
Maximal pain	5	5
Average pain	2	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Maximal pain
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.913
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Average pain
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.722
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Complications
Description	Patients with complications requiring treatment the first 24 hours (PACU and ward)
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	32	32
Count of Participants [Participants]	24 75%	25 78.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.768
	Comments
	Method	Chi-squared, Corrected
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.190
	Confidence Interval	(2-Sided) 95%; 0.374 to 3.793
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Self Reported Postoperative Pain
Description	Self-reported pain on a Numeric rating scale (NRS), NRS 0-10, 0 = no pain, 10= worst pain imaginable. Reported once daily, postoperative days 0 to 4
Time Frame	postoperative day 0 to 4, once a day

Outcome Measure Data

Analysis Population Description

Missing data, missing at random

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	26	25
Day 0	3 (2)	4 (2)
Day 1	4 (2)	4 (2)
Day 2	3 (2)	4 (2)
Day 3	3 (2)	3 (2)
Day 4	3 (2)	3 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.133
	Comments
	Method	Regression, Linear
	Comments

7. Secondary Outcome

Title	Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4
Description	Patients reporting PONV and/or receiving antiemetic medication on postoperative days 0 to 4
Time Frame	postoperative day 0 to 4, once a day

Outcome Measure Data

Analysis Population Description

Missing data day 4 due to discharge from hospital

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	32	32
Day 0	7 21.9%	8 25%
Day 1	6 18.8%	9 28.1%
Day 2	9 28.1%	11 34.4%
Day 3	7 21.9%	4 12.5%
Day 4	3 9.4%	2 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 0
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.768
	Comments	Not adjusted for multiple comparisons, statistical level of significance 0.01 (bonferroni correction)
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 1
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.376
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 2
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.590
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 3
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.320
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 4
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.666
	Comments
	Method	Chi-squared, Corrected
	Comments

8. Secondary Outcome

Title	Number of Patients With Sleep Problems
Description	Self-reported quality of sleep (days 0-4). Questionnaire. Results dichotomized to sleep problems (trouble falling asleep, frequent awakenings, no sleep) or no sleep problems.
Time Frame	4 days

Outcome Measure Data

Analysis Population Description

Missing data from questionnaires, missing at random, not filled out or not sent back

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	26	25
Day 0	13 40.6%	12 37.5%
Day 1	9 28.1%	13 40.6%
Day 2	8 25%	9 28.1%
Day 3	9 28.1%	9 28.1%
Day 4	8 25%	8 25%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 0
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.999
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 1
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.154
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 2
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.447
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 3
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.678
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 4
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.604
	Comments
	Method	Chi-squared, Corrected
	Comments

9. Secondary Outcome

Title	Number of Patients With Feelings of Anxiety, Unrest and/or Sadness
Description	Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire
Time Frame	postoperative day 0 to 4, once a day

Outcome Measure Data

Analysis Population Description

Missing data from questionnaires, missing at random

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	26	25
Day 0 : sadness	8 25%	2 6.3%
Day 0 : restlessness	11 34.4%	8 25%
Day 0 : fatigue	23 71.9%	21 65.6%
Day 1 : sadness	6 18.8%	4 12.5%
Day 1 : restlessness	3 9.4%	8 25%
Day 1 : fatigue	20 62.5%	17 53.1%
Day 2 : sadness	8 25%	8 25%
Day 2 : restlessness	6 18.8%	11 34.4%
Day 2 : fatigue	21 65.6%	14 43.8%
Day 3 : sadness	9 28.1%	6 18.8%
Day 3 : restlessness	9 28.1%	8 25%
Day 3 : fatigue	17 53.1%	13 40.6%
Day 4 : sadness	8 25%	5 15.6%
Day 4 : restlessness	10 31.3%	3 9.4%
Day 4 : fatigue	17 53.1%	10 31.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 0, sadness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.075
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 0, restlessness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.447
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 0, fatigue
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.703
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 1, sadness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.731
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 1, restlessness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.052
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 1, fatigue
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.807
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 2, sadness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.371
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 2, restlessness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.064
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	day 2, fatigue
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.110
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 3, sadness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.531
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 3, restlessness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.954
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 3, fatigue
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.526
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 4, sadness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.491
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 4, restlessness
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.042
	Comments
	Method	Chi-squared, Corrected
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments	Day 4, fatigue
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.097
	Comments
	Method	Chi-squared, Corrected
	Comments

10. Secondary Outcome

Title	Number of Patients Readmitted to Hospital Within 30 Days
Description	Any readmission within 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	32	32
Count of Participants [Participants]	1 3.1%	3 9.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexamethasone 48 mg, Dexamethasone 8 mg
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.613
	Comments
	Method	Chi-squared, Corrected
	Comments

11. Secondary Outcome

Title	Number of Patients With Wound Infections Within 30 Days
Description	Any wound infections/complications
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone 48 mg	Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Measure Participants	32	32
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	60 hours after administration of trial drug(collection of possible adverse drug reactions), for readmissions and woundinfections: 30 days.
Arm/Group Title	Dexamethasone 48 mg		Dexamethasone 8 mg
Arm/Group Description	Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous		Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
All Cause Mortality
	Dexamethasone 48 mg		Dexamethasone 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Serious Adverse Events
	Dexamethasone 48 mg		Dexamethasone 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/32 (3.1%)		0/32 (0%)
Surgical and medical procedures
bleeding, intraoperative	1/32 (3.1%)	1	0/32 (0%)	0
Other (Not Including Serious) Adverse Events
	Dexamethasone 48 mg		Dexamethasone 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (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.