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

West Virginia University

Status: Completed

Conditions: Injury as a Result of Positioning

Treatments: Device: NIRS; Device: NIRS monitored not treated

Study type: Interventional

Funder types: Other

Identifiers

NCT02674334

1409418786

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

NIRS Monitored Not Treated

Active Comparator group

Description:

Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS)

Treatment:

Device: NIRS monitored not treated

NIRS Monitored and Treated

Active Comparator group

Description:

Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS)

Treatment:

Device: NIRS