Clinical trial

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.

Name

Dexamethasone-2014-4

Description

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 arms

Trial start

2014-11-01

Estimated PCD

2015-11-01

Trial end

2016-11-01

Status

Completed

Phase

Early phase I

Treatment

Intravenous Dexamethasone

One dose of intravenous dexamethasone (8 mg) 60 minutes before surgery.

Arms:

dexamethasone group

Other names:

no other intervention

intravenous salin water

Patients of the control group received homologated placebo 60 minutes before surgery.

Arms:

placebo group

Other names:

no other intervention

Size

120

Primary endpoint

Change in Forced Vital Capacity (FVC), measured in Liters/second and in percentage %.

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 %.

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 %.

change occurred from 1 hour before surgery and after 1, 6, 12 and 24 postoperative hours

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

Updated at

2023-10-03

1 organization

2 products

3 indications

Organization

Instituto Mexicano del Seguro Social

Product

Indication

Indication

Indication

Product