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

NCT ID: NCT01854515

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31

Brief 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

Conditions

Respiratory Sounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Budesonide

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 h. for 48 h.

Group Type: ACTIVE_COMPARATOR

Budesonide

Intervention Type: DRUG

Dexamethasone

0.15 mg/kg before extubation. After extubation, the administration of intravenous Dexamethasone continued at the same dose every 12 h. for 48 h.

Group Type: EXPERIMENTAL

Dexamethasone acetate

Intervention Type: DRUG

Interventions

Budesonide

Intervention Type: DRUG

Dexamethasone acetate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saeed Abbasi

OTHER

Sponsor Role: lead

Responsible Party

Saeed Abbasi

Assistant Professor in Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Alzahra University Hospital

Isfahan, Isfahan, Iran

Site Status: RECRUITING

Countries

Iran

Facility Contacts

Saeed Abbasi, Assistant Professor

Role: primary

s_abbasi@med.mui.ac.ir

00989131135730

Other Identifiers

391387

Identifier Type: -

Identifier Source: org_study_id