West Virginia University
Morgantown, West Virginia, 26506-9196, United States
Completed
NCT Number: NCT02674334
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
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.
Completed
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Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- at least 18 years of age
- elective shoulder surgery in the beach chair position
Exclusion criteria
- less than 18 years of age
- preoperative score of 23 or less on the pre-operative Mini Mental State Exam
- traumatic brain injury
- transient ischemic attack
- cerebrovascular incident
- any apparent clinical neurologic dysfunction
- carotid artery stenosis
- known vascular malformation in head
- inability to have blood pressure measured in the opposite extremity
- malignant hyperthermia
Treatment and study plan
NIRS
DeviceNear 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
Other names: Near infrared spectroscopy
NIRS monitored not treated
DeviceNear infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.
Other names: Near infrared spectroscopy
Primary outcomes
-
Percentage of Participants With 20+% Cerebral Desaturation Events
Time frame: one day
Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position
Secondary outcomes
-
Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value
Time frame: baseline and up to two weeks
Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) > 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value.
Sponsors and collaborators
Lead sponsor
West Virginia University
Other
Registry information
Acronym: BCP
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Feb 4, 2016
- Registry last updated
- Sep 11, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.