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NCT Number: NCT03125941

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy

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.

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Key information

Conditions

Dexamethasone Breast Cancer Breast Diseases Breast Neoplasms Glucocorticoids Inflammation Mastectomy Nausea Nausea and Vomiting, Postoperative Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Shock Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Steroid Systemic Inflammatory Response Syndrome Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

pre-operative intravenous administration

Primary outcomes

  1. Transfer to Post-anesthesia Care Unit (PACU)

    Time frame: Within 1 hour post-surgery

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

Secondary outcomes

  1. Discharge Score,(Modified Aldrete Discharge Score), Operating Room

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 24 hours

    complications requiring treatment until discharge

  5. Total Length of Stay in PACU

    Time frame: 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

    Time frame: 24-48 hours

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

  7. Secondary Transfer

    Time frame: 24-48 hours

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

  8. Pain, Numeric Rating Scale

    Time frame: 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).

    Time frame: days 0-4

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

  10. Quality of Sleep

    Time frame: 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

    Time frame: 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

    Time frame: 14 days

    Seroma, requiring treatment the first 14 days.

  13. Readmission

    Time frame: 30 days

    Any readmission, days 0-30

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Effect of High vs Low Dose Intravenous Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy- a Randomized, Double-blind, Controlled Trial

Acronym: DEX-MAS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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