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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000227-27 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone 8 mg | Active Comparator | Dexamethasone 8 mg pre-operative |
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| Dexamethasone 24 mg | Active Comparator | Dexamethasone 24 mg pre-operative |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | pre-operative intravenous administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Transfer to Post-anesthesia Care Unit (PACU) | Number of patients meeting criteria for transfer to PACU post-surgery | Within 1 hour post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin J Steinthorsdottir, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
Not planned to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone 8 mg | Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration |
| FG001 | Dexamethasone 24 mg | Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2018 |
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| At transfer from operating room, within 1 hour post-surgery |
| 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 |
| 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 |
| Number of Participants With Complication | complications requiring treatment until discharge | 24 hours |
| 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 |
| 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 Transfer | Secondary transfer to PACU from ward, or to intensive care unit from PACU | 24-48 hours |
| 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 |
| Post Operative Nausea and Vomiting (PONV). | Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting | days 0-4 |
| 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 |
| 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 |
| Number of Participants With Seroma, Requiring Treatment | Seroma, requiring treatment the first 14 days. | 14 days |
| Readmission | Any readmission, days 0-30 | 30 days |
| Post-randomization Exclusion |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone 8 mg | Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration |
| BG001 | Dexamethasone 24 mg | Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Transfer to Post-anesthesia Care Unit (PACU) | Number of patients meeting criteria for transfer to PACU post-surgery | primary outcome was per intention to treat, secondary outcomes were per protocol (we had 3 post-randomization exclusions, that did not receive the intervention) | Posted | Count of Participants | Participants | Within 1 hour post-surgery |
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| 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. | Posted | Median | Inter-Quartile Range | score on a scale | At transfer from operating room, within 1 hour post-surgery |
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| 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. | Posted | Median | Inter-Quartile Range | score on a scale | within 3 hours |
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| 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. | Posted | Median | Inter-Quartile Range | score on a scale | within 3 hours |
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| Secondary | Number of Participants With Complication | complications requiring treatment until discharge | Posted | Count of Participants | Participants | 24 hours |
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| 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 | Posted | Median | Inter-Quartile Range | hours | 12 hours |
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| Secondary | Total Length of Stay in Hospital | Length of stay in hospital, measured from start of procedure to discharge from hospital to home | Posted | Median | Inter-Quartile Range | hours | 24-48 hours |
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| Secondary | Secondary Transfer | Secondary transfer to PACU from ward, or to intensive care unit from PACU | Posted | Count of Participants | Participants | 24-48 hours |
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| 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. | Posted | Median | Inter-Quartile Range | score on a scale | days 0-4 |
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| Secondary | Post Operative Nausea and Vomiting (PONV). | Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting | Posted | Count of Participants | Participants | days 0-4 |
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| 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 | Posted | Count of Participants | Participants | days 0-4 |
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| 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) | Posted | Count of Participants | Participants | days 0-4 |
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| Secondary | Number of Participants With Seroma, Requiring Treatment | Seroma, requiring treatment the first 14 days. | Posted | Count of Participants | Participants | 14 days |
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| Secondary | Readmission | Any readmission, days 0-30 | Posted | Count of Participants | Participants | 30 days |
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone 8 mg | Dexamethasone 8 mg pre-operative Dexamethasone: pre-operative intravenous administration | 0 | 63 | 5 | 63 | 0 | 63 |
| EG001 | Dexamethasone 24 mg | Dexamethasone 24 mg pre-operative Dexamethasone: pre-operative intravenous administration | 0 | 64 | 3 | 64 | 0 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound hemorrhage | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| kristin steinthorsdottir, md | rigshospitalet | 31666112 | kjs@dadlnet.dk |
| Oct 17, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D018746 | Systemic Inflammatory Response Syndrome |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D007249 | Inflammation |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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