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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Injury as a Result of Positioning

Intervention / Treatment
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* Device: NIRS
* Device: NIRS monitored not treated


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIRS Monitored Not Treated<br>Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS) | Device: NIRS monitored not treated<br>* Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.<br>* Other names: Near infrared spectroscopy;|
| Active Comparator: NIRS Monitored and Treated<br>Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS) | Device: NIRS<br>* 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<br>* Other names: Near infrared spectroscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With 20+% Cerebral Desaturation Events | 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 | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value | 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. | baseline and up to two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthopedic procedures