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

NCT01854515 | Unknown

• 1 other identifier: 391387
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• post extubation stridor

  Until 48 hours after extubation we documented if there is stridor in examination

  After extubation until 48 hours

Study Arms (2)

Budesonide

ACTIVE COMPARATOR

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.

Drug: Budesonide

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone acetate

Interventions

Budesonide DRUG

Budesonide

Dexamethasone acetate DRUG

Dexamethasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients' age 18-65 years old
• Intubated for more than 48 hours after surgery
• 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

You may not qualify if:

• Any history of corticosteroid therapy in previous week
• Nasal or throat disease / surgery
• Pulmonary airway disease
• Gastrointestinal bleeding

Sponsors & Collaborators

• Saeed Abbasi: lead

Study Sites (1)

Alzahra University Hospital

Isfahan, Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Interventions

Budesonide; dexamethasone acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Anesthesiology

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 15, 2013
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

IR (1)