Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273754
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2006-01-04
Brief Title:
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea OSA
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Pilot Study to Evaluate if Caffeine Helps Children With Obstructive Sleep Apnea Recover Faster From Anesthesia and With Less Complications After General Anesthesia for Tonsillectomy and Adenoidectomy
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
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:
OSA
Brief Summary:
This is a research study using caffeine in children who have an obstructive sleep apnea OSA OSA means children who stop breathing during their sleep due to obstruction in their airway The purpose of this study is to determine whether caffeine when given in the vein will wake children up faster and decrease post-anesthesia airway obstruction as well as the safety and if the drug agrees with the child compared to a placebo an inactive or dummy agent
Detailed Description:
Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia Children with OSA especially those under three years of age those with severe OSA cerebral palsy or craniofacial anomalies are at increased risks for post-operative complications and require careful monitoring post-operatively
Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities we believe that a central element may contribute to OSA
The aim of this study is to evaluate whether administration of caffeine to children with OSA scheduled for elective T A under general anesthesia contributes to a faster recovery less post-operative complications and a shorter stay in the PACU DSU and the hospital
Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities we believe that a central element may contribute to OSA
The aim of this study is to evaluate whether administration of caffeine to children with OSA scheduled for elective T A under general anesthesia contributes to a faster recovery less post-operative complications and a shorter stay in the PACU DSU and the hospital
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