Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-28 @ 6:41 PM
Study NCT ID:
NCT02240368
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2014-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
Sponsor:
University of Foggia
Organization:
Study Overview
Official Title:
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.
Status:
COMPLETED
Status Verified Date:
2018-07
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:
The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting.
Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia.
Their utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.
Bispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia.
Their utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.
Detailed Description:
All patients monitored applying standard device for blood pressure, electrocardiogram and pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators will not assign any specific interventions to the subjects of the study.
Study Oversight
Has Oversight DMC:
True
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?: