Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01854515
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
2013-05-13
Brief Title:
Comparison of Efficacy of Nebulizing Budesonide and Intravenous Dexamethasone Before Extubation on Prevention of Post-extubation Complications in Intensive Care Unit Patients
Sponsor:
Saeed Abbasi
Organization:
Isfahan University of Medical Sciences
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hi In dexamethasone group intravenous dexamethasone was administered to patient at a dose of 015 mgkg 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 248122436 and 48 hrs After extubation then the presence of stridor heard with the aid of stethoscope was recorded within 48 hr of extubation
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 hi In dexamethasone group intravenous dexamethasone was administered to patient at a dose of 015 mgkg 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 248122436 and 48 hrs After extubation then the presence of stridor heard with the aid of stethoscope was recorded within 48 hr of extubation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None