Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01633320
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2012-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI)
Sponsor:
Hôpital Edouard Herriot
Organization:
Study Overview
Official Title:
Non-invasive Assessment of Immediate Postoperative Analgesia Using Analgesia/Nociception Index (ANI): A Prospective and Observational Study
Status:
COMPLETED
Status Verified Date:
2012-11
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 aim of this study is to evaluate the clinical performance on Analgesia/Nociception Index (ANI) in the assessment of immediate postoperative analgesia in PACU in adult patients undergoing general anesthesia.
Detailed Description:
Evaluation of the relationship between ANI and numerical rating pain scale (NRS) by linear regression.
Assessment of the performance of ANI to detect NRS\>3 and NRS\>=7 by building ROC curves.
Assessment of the performance of ANI to detect NRS\>3 and NRS\>=7 by building ROC curves.
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?: