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

NCT ID: NCT02674334

Last Updated: 2017-09-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-05-31

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.

Conditions

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Injury as a Result of Positioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NIRS Monitored Not Treated

Anesthesiologist blinded to Near Infrared Spectroscopy (NIRS)

Group Type ACTIVE_COMPARATOR

NIRS monitored not treated

Intervention Type DEVICE

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

NIRS Monitored and Treated

Anesthesiologist treats based on Near Infrared Spectroscopy (NIRS)

Group Type ACTIVE_COMPARATOR

NIRS

Intervention Type DEVICE

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

Interventions

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NIRS

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

Intervention Type DEVICE

NIRS monitored not treated

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

Intervention Type DEVICE

Other Intervention Names

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Near infrared spectroscopy Near infrared spectroscopy

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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George K Bal

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George K Bal, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

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West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1409418786

Identifier Type: -

Identifier Source: org_study_id

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