Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482125
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-25
Brief Title:
Emergence Agitation is a Problem in Pediatric Anesthesia We Aim to Lower Its Incidence by Using Dexmedetomidine
Sponsor:
Pelita Harapan University
Organization:
Pelita Harapan University
Study Overview
Official Title:
Comparison of Emergence Agitation Between Total Intravenous Dexmedetomidine Versus Inhalation Sevoflurane in Pediatrics Undergoing Cleft Lip and Palate Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Emergence agitation is commonly encountered after receiving inhalation anesthesia This distressing phenomenon carries risks that are harmful to patients caregivers and medical personnel Using total intravenous Dexmedetomidine the investigators seek to reduce agitation and provide gentle emergence from anesthesia
Detailed Description:
Surgery for pediatric cleft lip and palate repair often utilizes high dose opioids and inhaled anaesthesia thereby causing postoperative complications such as desaturation andor severe agitation after anesthesia These complications are detrimental to the child medical personnel and causes tremendous psychologic stress to parents This study aims to decrease these complications through Dexmedetomidine an Alpha-2 receptor agonist with anxiolytic sympatholytic and analgetic properties Devoid of respiratory depressant effect it allows patients to maintain effective ventilation and reduce agitation postoperatively Its unique anesthetic property may shed light to provide safe anesthesia and gentle emergence to this young vulnerable population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None