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

West Virginia University90 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Injury as a Result of Positioning

Interventions

NIRSDEVICE

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

NIRS monitored not treatedDEVICE

Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

West Virginia University

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

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

Time frame: one day

Secondary Outcomes

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.

Time frame: baseline and up to two weeks

Data from ClinicalTrials.gov

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