Comparison of Efficacy of Nebulizing Budesonide and Intravenous Dexamethasone Before Extubation on Prevention of Post-extubation Complications in Intensive Care Unit Patients

Respiratory Sounds Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01854515
• Other study ID #: 391387
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2013
• Last updated: May 14, 2013
• Start date: March 2012

Study information

• Verified date: May 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The present study was aimed at investigating the efficacy of nebulizing Budesonide sin comparison with intravenous Dexamethasone before extubation in prevention of post-extubation complications amongst patients admitted in intensive care unit.

In this double-blind randomized clinical trial study, 90 patients (age between 18 to 65) who are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in the study after obtaining a written informed consent from their parents or guardians.

The investigators divide our patients randomly into two equal groups.

-In the budesonide group patients underwent a therapy with nebulizing Budesonide at a dose of 1 mg diluted in 4 cc of sterile water for 20 minutes, one hour preceding extubation. After extubation patients received nebulizing budesonide via oxygen mask at the same dose every 12 hours for 48 h.i In dexamethasone group intravenous dexamethasone was administered to patient at a dose of 0.15 mg/kg before extubation. After extubation, the administration of intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.

Another anesthesiologist who is unaware about kind of medication, will evaluate the patients for severity of stridor. We will record the vital sings and grade of stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of extubation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients' age 18-65 years old

2. Intubated for more than 48 hours after surgery

3. Met the weaning criteria defined as respiratory rate < 30 breaths / min, negative tidal volume > 5 ml/kg ideal body weight, and shallow index (respiratory rate/tidal volume) < 105 breaths / min/L

Exclusion Criteria:

1. Any history of corticosteroid therapy in previous week

2. Nasal or throat disease / surgery

3. Pulmonary airway disease

4. Gastrointestinal bleeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Sounds

Intervention

Drug:
• Budesonide

• Dexamethasone acetate

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alzahra University Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Saeed Abbasi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post extubation stridor	Until 48 hours after extubation we documented if there is stridor in examination	After extubation until 48 hours	Yes