Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-06 @ 10:08 PM
Study NCT ID:
NCT02521259
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery
Sponsor:
Seoul National University Bundang Hospital
Organization:
Study Overview
Official Title:
The Correlation Between Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery
Status:
COMPLETED
Status Verified Date:
2019-09
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:
This study evaluates the association between the depth of general anesthesia and the occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery compared to the deep level of anesthetic depth.
Detailed Description:
EA is characterized by dissociated state of consciousness, in which the children are inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent.
Several predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head \& neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.
The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically.
In this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.
Several predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head \& neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.
The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically.
In this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.
Study Oversight
Has Oversight DMC:
False
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?: