Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position

Not Applicable

Completed

• Conditions: Injury as a Result of Positioning
• Interventions: Device: NIRS monitored not treated; Device: NIRS

• Registration Number: NCT02674334
• Lead Sponsor: West Virginia University

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 Timeline

• Study Start: 2012-10
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-04
• Results First Submitted: 2016-11-09
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-09
• Last Update Submitted: 2017-08-09
• Results First Posted: 2017-09-11
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIRS Monitored Not Treated	NIRS monitored not treated	Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS)
NIRS Monitored and Treated	NIRS	Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With 20+% Cerebral Desaturation Events	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 Outcome Measures

Name	Time	Method
Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value	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.

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States