Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-04-21 @ 9:13 AM
Study NCT ID:
NCT02674334
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
Sponsor:
West Virginia University
Organization:
Study Overview
Official Title:
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
Status:
COMPLETED
Status Verified Date:
2017-08
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:
BCP
Brief Summary:
The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.
Detailed Description:
In this prospective, randomized, controlled study, investigators used a standardized anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia management and would not affect the post-operative cognitive outcomes of participants undergoing surgery in the beach chair position. Investigators secondarily wanted to document the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in participants placed in the BCP if the MAP was strictly maintained.
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?: