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Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.
All subjects will complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concussion Group | Experimental | Subjects diagnosed with concussion defined as a clinician-diagnosed disease by the International Classification of Diseases (ICD)-10 due to a head injury with a Glasgow Coma Score ≥13 undergoing a planned surgery/anesthetic standard of care will undergo neurocognitive testing pre and post surgery/anesthetic. |
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| Matched Subjects Group | Experimental | Matched subjects without concussion undergoing a planned surgery/anesthetic standard of care, matching for procedural type, sex, age ± 2 years, and adherence to the exclusion criteria will undergo neurocognitive testing pre and post surgery/anesthetic. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurocognitive Testing | Other | A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Wide Range Achievement Test Fourth Edition, WRAT-4 | Change in WRAT-4 | Pre-anesthetic to one week Post-anesthetic |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Scale 0-10 | Difference in numeric pain scale between the concussion and non-concussion group. Patients verbally select a value that is in line with the intensity of pain they have experienced in the last 24 hours. Pain Scale is recorded "0" = no pain, "10" = the most pain imaginable. | Post-operatively to hospital discharge, up to 10 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnoley S Abcejo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Oral morphine equivalent of consumed opioids | Difference of post-operative opioid use between the concussion and non-concussion group | Post-operatively to hospital discharge, up to 10 days. |
| Length of hospital stay | Difference between the concussion and non-concussion group | Post-operatively to hospital discharge, up to 30 days. |
| Cognitive Deficits identified by NeuroPsychometric Cognitive Testing | Difference between the concussion and non-concussion group. | Pre-anesthetic to one week Post-anesthetic |
| Sport Concussion Assessment Tool - 5th edition, SCAT-5 | The SCAT5 is a standardized tool for evaluating concussions designed for use by physicians and licensed medical professionals. Difference in SCAT5 scores between the concussion and non-concussion group. SCAT5 scores the number of symptoms (0-22) present and the severity of symptoms (0-132). | Pre-anesthetic to one week Post-anesthetic |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |