N/A N=90 Randomized Double-blind Treatment

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

Injury as a Result of Positioning

Bottom Line

View on ClinicalTrials.gov: NCT02674334 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcome: Primary: Percentage of Participants With 20+% Cerebral Desaturation Events — 40; 40 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NIRS (Device); NIRS monitored not treated (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: West Virginia University
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With 20+% Cerebral Desaturation Events	40; 40	—
SECONDARY Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value	-1.33; -.17	0.165

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02674334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.