Dexamethasone and Respiratory Function After Mastectomy
Dexa-mama
Effect of the Preoperative Administration of Dexamethasone in the Respiratory Function and Postoperative Symptoms in Women Undergoing Mastectomy for Cancer. Results of a Randomized Clinical Trial.
1 other identifier
interventional
120
1 country
1
Brief Summary
Preoperative dexamethasone reduces symptoms after different surgical procedures including mastectomy in breast cancer, but the effect in the postoperative respiratory function remains unknown. The aim of this protocol was to determine if the administration of a single dose of dexamethasone during the preoperative, could improve respiratory function and postoperative symptoms of patients undergoing mastectomy in breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 20, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedOctober 3, 2023
September 1, 2023
1 year
November 20, 2014
September 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Forced Vital Capacity (FVC), measured in Liters/second and in percentage %.
maximum amount of air a person can expel from the lungs after a maximum inhalation.
change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours
Change in Forced Espiratory Volume (FEV) in the first second, measured in Liters/second and in percentage %.
Measures the amount of air a person can exhale during a forced breath in one second.
change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours
Change in Peak Respiratory Flow (PRF). measured in Liters/second and in percentage %.
A person maximum speed of expiration
change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours
Secondary Outcomes (7)
Change in pain occurred from 1 hour before surgery and after 1, 6, 12 and 24 hours after surgery.
change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours
Change in nausea occurred from 1 hour before surgery, and after 1, 6, 12 and 24 hours after surgery.
change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours
Change in vomiting occurred from 1 hour before surgery, and after 1, 6, 12 and 24 hours after surgery.
change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours
Total dose of backup analgesic medication administrated to each patient
24 hours after surgery
Total dose of backup antiemetic medication administrated to each patient
24 hours after surgery
- +2 more secondary outcomes
Study Arms (2)
dexamethasone group
ACTIVE COMPARATORpatients receive one single dose of intravenous dexamethasone 8 mg.
placebo group
PLACEBO COMPARATORpatients receive one single dose of intravenous placebo.
Interventions
One dose of intravenous dexamethasone (8 mg) 60 minutes before surgery.
Patients of the control group received homologated placebo 60 minutes before surgery.
Eligibility Criteria
You may qualify if:
- confirmed diagnosis of breast carcinoma
You may not qualify if:
- patients with a classification of the American Society of Anesthesiologists classes III and IV.
- pregnancy
- during menstruation
- during steroid therapy
- severe diabetes mellitus (serum HbA1c\> 8%)
- opioids, sedatives or painkillers less than a week before the mastectomy
- history of alcohol or drugs
- patients with a history of inner ear disease and / or severe PONV after any surgical procedure performed in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Unit in Clinical Epidemiology, Specialties Hospital. Mexican Institute of Social Security
Guadalajara, Jalisco, Mexico
Related Publications (1)
Jimenez-Tornero J, Cortes-Flores AO, Chavez-Tostado M, Morgan-Villela G, Zuloaga-Fernandez Del Valle C, Zuloaga-Fernandez Del Valle R, Garcia-Gonzalez LA, Fernandez-Avalos VS, Miranda-Ackerman RC, Alvarez-Villasenor AS, Ambriz-Gonzalez G, Barbosa-Camacho FJ, Fuentes-Orozco C, Contreras-Cordero VS, Gonzalez-Ojeda A. Effect of a preoperative single-dose steroid on pulmonary function and postoperative symptoms after modified radical mastectomy: results of a randomized clinical trial. Gland Surg. 2020 Oct;9(5):1313-1327. doi: 10.21037/gs-20-366.
PMID: 33224806DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
González-Ojeda Alejandro, PhD. MD.
Instituto Mexicano del Seguro Social
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Alejandro González-Ojeda, Ph.D., M.D.
Study Record Dates
First Submitted
November 20, 2014
First Posted
December 2, 2014
Study Start
November 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2016
Last Updated
October 3, 2023
Record last verified: 2023-09