N/A
Completed N=90
Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
Injury as a Result of Positioning
Source: ClinicalTrials.gov NCT02674334 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With 20+% Cerebral Desaturation Events — 40; 40 Participants
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.
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 |
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
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. Informational only — not medical advice.