Dexamethasone and Respiratory Function After Mastectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT02305173
• Date of registration: 20/11/2014
• Prospective Registration: No
• Primary sponsor: Instituto Mexicano del Seguro Social
• Public title: Dexamethasone and Respiratory Function After Mastectomy Dexa-mama
• Scientific title: 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.
• Date of first enrolment: November 2014
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02305173
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Mexico

Contacts

• Name: González-Ojeda Alejandro, PhD. MD.
• Affiliation: Instituto Mexicano del Seguro Social

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 69 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Respiratory; Disorder, Functional, Impaired

Intervention(s)

Drug: Intravenous Dexamethasone

Drug: intravenous salin water

Primary Outcome(s)

Change in Forced Vital Capacity (FVC), measured in Liters/second and in percentage %. [Time Frame: 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 %. [Time Frame: 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 %. [Time Frame: change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours]

Secondary Outcome(s)

Morbidity after mastectomy [Time Frame: 24 postoperative hours and until 8 days after surgery after hospital discharge.]

Change in nausea occurred from 1 hour before surgery, and after 1, 6, 12 and 24 hours after surgery. [Time Frame: change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours]

Total dose of backup antiemetic medication administrated to each patient [Time Frame: 24 hours after surgery]

Total dose of backup analgesic medication administrated to each patient [Time Frame: 24 hours after surgery]

Change in vomiting occurred from 1 hour before surgery, and after 1, 6, 12 and 24 hours after surgery. [Time Frame: change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours]

Change in Oximetry (percentage %). [Time Frame: change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours]

Change in pain occurred from 1 hour before surgery and after 1, 6, 12 and 24 hours after surgery. [Time Frame: change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours]

Secondary ID(s)

Dexamethasone-2014-4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors