Trial Outcomes & Findings for High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy (NCT NCT03125941)

NCT ID: NCT03125941

Last Updated: 2019-12-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 130 participants
• Primary outcome timeframe: Within 1 hour post-surgery
• Results posted on: 2019-12-02

Participant Flow

Participant milestones

Measure	Dexamethasone 8 mg Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Overall Study STARTED	65	65
Overall Study Post-randomization Exclusion	1	2
Overall Study COMPLETED	64	63
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Dexamethasone 8 mg Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Overall Study did not receive intervention	1	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Dexamethasone 8 mg n=65 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=65 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration	Total n=130 Participants Total of all reporting groups
Age, Continuous	66 years n=65 Participants	63 years n=65 Participants	65 years n=130 Participants
Sex: Female, Male Female	63 Participants n=65 Participants	65 Participants n=65 Participants	128 Participants n=130 Participants
Sex: Female, Male Male	2 Participants n=65 Participants	0 Participants n=65 Participants	2 Participants n=130 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Within 1 hour post-surgery

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

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

Outcome measures

Measure	Dexamethasone 8 mg n=65 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=65 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Transfer to Post-anesthesia Care Unit (PACU)	23 Participants	23 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Dexamethasone 8 mg n=63 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Discharge Score,(Modified Aldrete Discharge Score), Operating Room	0 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Dexamethasone 8 mg n=63 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Discharge Score, Arrival at PACU	1 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Dexamethasone 8 mg n=63 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Discharge Score, Arrival at Ward	1 score on a scale Interval 1.0 to 2.0	1 score on a scale Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 24 hours

complications requiring treatment until discharge

Outcome measures

Measure	Dexamethasone 8 mg n=63 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Number of Participants With Complication	12 Participants	9 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Dexamethasone 8 mg n=12 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=12 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Total Length of Stay in PACU	1.5 hours Interval 1.4 to 2.4	1.5 hours Interval 1.4 to 1.6

SECONDARY outcome

Timeframe: 24-48 hours

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

Outcome measures

Measure	Dexamethasone 8 mg n=63 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Total Length of Stay in Hospital	9.2 hours Interval 7.4 to 24.4	11 hours Interval 8.1 to 23.5

SECONDARY outcome

Timeframe: 24-48 hours

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

Outcome measures

Measure	Dexamethasone 8 mg n=63 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Secondary Transfer	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Dexamethasone 8 mg n=52 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=56 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Pain, Numeric Rating Scale Day 4, average	1 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 0.0 to 1.0
Pain, Numeric Rating Scale Day 0, worst	3 score on a scale Interval 0.0 to 5.75	3 score on a scale Interval 1.0 to 5.0
Pain, Numeric Rating Scale Day 1, worst	2 score on a scale Interval 0.0 to 4.0	1.5 score on a scale Interval 1.0 to 3.0
Pain, Numeric Rating Scale Day 4, worst	1 score on a scale Interval 0.0 to 3.0	1 score on a scale Interval 0.0 to 2.0
Pain, Numeric Rating Scale Day 0, average	2 score on a scale Interval 0.0 to 4.0	2 score on a scale Interval 1.0 to 4.0
Pain, Numeric Rating Scale Day 1, average	2 score on a scale Interval 0.0 to 3.0	1 score on a scale Interval 1.0 to 2.0
Pain, Numeric Rating Scale Day 2, average	1 score on a scale Interval 0.0 to 3.0	1 score on a scale Interval 0.0 to 2.0
Pain, Numeric Rating Scale Day 3, average	1 score on a scale Interval 0.0 to 2.0	1 score on a scale Interval 0.0 to 1.0
Pain, Numeric Rating Scale Day 2, worst	2 score on a scale Interval 0.0 to 4.0	2 score on a scale Interval 0.0 to 3.0
Pain, Numeric Rating Scale Day 3, worst	1 score on a scale Interval 0.0 to 1.0	1 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: days 0-4

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

Outcome measures

Measure	Dexamethasone 8 mg n=52 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=56 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Post Operative Nausea and Vomiting (PONV). DAY 3	7 Participants	6 Participants
Post Operative Nausea and Vomiting (PONV). DAY 0	6 Participants	11 Participants
Post Operative Nausea and Vomiting (PONV). DAY 1	6 Participants	10 Participants
Post Operative Nausea and Vomiting (PONV). DAY 2	6 Participants	9 Participants
Post Operative Nausea and Vomiting (PONV). DAY 4	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Dexamethasone 8 mg n=52 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=56 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Quality of Sleep DAY 0	31 Participants	39 Participants
Quality of Sleep DAY 1	20 Participants	22 Participants
Quality of Sleep DAY 2	24 Participants	18 Participants
Quality of Sleep DAY 3	18 Participants	17 Participants
Quality of Sleep DAY 4	17 Participants	16 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Dexamethasone 8 mg n=52 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=56 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Mental Status DAY 4 : sadness	14 Participants	12 Participants
Mental Status DAY 4 : fatigue	14 Participants	15 Participants
Mental Status DAY 0 : restlessness	17 Participants	20 Participants
Mental Status DAY 0 : sadness	14 Participants	18 Participants
Mental Status DAY 0 : fatigue	26 Participants	28 Participants
Mental Status DAY 1 : restlessness	9 Participants	9 Participants
Mental Status DAY 1 : sadness	13 Participants	13 Participants
Mental Status DAY 1 : fatigue	11 Participants	27 Participants
Mental Status DAY 2 : restlessness	14 Participants	8 Participants
Mental Status DAY 2 : sadness	14 Participants	18 Participants
Mental Status DAY 2 : fatigue	16 Participants	17 Participants
Mental Status DAY 3 : restlessness	11 Participants	8 Participants
Mental Status DAY 3 : sadness	14 Participants	20 Participants
Mental Status DAY 3 : fatigue	14 Participants	17 Participants
Mental Status DAY 4 : restlessness	13 Participants	13 Participants

SECONDARY outcome

Timeframe: 14 days

Seroma, requiring treatment the first 14 days.

Outcome measures

Measure	Dexamethasone 8 mg n=63 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Number of Participants With Seroma, Requiring Treatment	51 Participants	60 Participants

SECONDARY outcome

Timeframe: 30 days

Any readmission, days 0-30

Outcome measures

Measure	Dexamethasone 8 mg n=63 Participants Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 Participants Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Readmission	4 Participants	4 Participants

Adverse Events

Dexamethasone 8 mg

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone 24 mg

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexamethasone 8 mg n=63 participants at risk Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration	Dexamethasone 24 mg n=64 participants at risk Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration
Surgical and medical procedures wound hemorrhage	7.9% 5/63 • Number of events 5 • 60 hours from administration of study drug 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	4.7% 3/64 • Number of events 3 • 60 hours from administration of study drug 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

Other adverse events

Adverse event data not reported

Additional Information

kristin steinthorsdottir, md

rigshospitalet

Phone: 31666112

Email: kjs@dadlnet.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place