Clinical trial · Interventional
Dexamethasone and Respiratory Function After Mastectomy
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Respiratory; Disorder, Functional, Impaired | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Dexamethasone | Drug | Dexamethasone | ALIAS |
| intravenous salin water | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- dexamethasone group
- description
- patients receive one single dose of intravenous dexamethasone 8 mg.
- interventionNames
- Drug: Intravenous Dexamethasone
- type
- PLACEBO_COMPARATOR
- label
- placebo group
- description
- patients receive one single dose of intravenous placebo.
- interventionNames
- Drug: intravenous salin water
Primary outcomes (3)
- measure
- Change in Forced Vital Capacity (FVC), measured in Liters/second and in percentage %.
- timeFrame
- change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * confirmed diagnosis of breast carcinoma Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDJimenez-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 33224806