Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-06-09 @ 1:31 PM
Study NCT ID:
NCT04603469
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2020-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypotension in Children With Down Syndrome With Anesthesia Induction
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Incidence of Hypotension in Children With Down Syndrome During Induction of Anesthesia With Sevoflurane
Status:
COMPLETED
Status Verified Date:
2022-07
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:
Children generally undergo induction of anesthesia by inhalation of sevoflurane. Children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.
Detailed Description:
Children generally undergo induction of anesthesia by inhalation of sevoflurane. This is particularly relevant for children with developmental delays as to avoid placement of an IV while awake. However, children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.
Study Oversight
Has Oversight DMC:
False
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?: