Trials / Completed
CompletedNCT02674334
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- West Virginia University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NIRS | Near infrared spectroscopy (NIRS) monitor allows anesthesiologist to treat cerebral desaturations according to NIRS results while maintaining Mean Arterial Pressure (MAP) at least 60mmHG or at least 80% of baseline |
| DEVICE | NIRS monitored not treated | Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2016-02-04
- Last updated
- 2017-09-11
- Results posted
- 2017-09-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02674334. Inclusion in this directory is not an endorsement.