Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

Not Applicable

Completed

• Conditions: Concussion, Brain
• Interventions: Other: Neurocognitive Testing

• Registration Number: NCT03952208
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.

Detailed Description

All subjects will complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.

Study Timeline

• Study Start: 2019-02-21
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Primary Completion: 2023-03-01
• Status Verified: 2025-04
• Study Completion: 2025-04-10
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Male or Female >16 years of age with a recent concussion (<10 weeks) from planned procedure under anesthesia.

Exclusion Criteria

• Neurologic history including history of severe cognitive disease, disorder, or delay, attention disorder, moderate to severe TBI history, neurovascular order or trauma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concussion Group	Neurocognitive Testing	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.
Matched Subjects Group	Neurocognitive Testing	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.

Primary Outcome Measures

Name	Time	Method
Wide Range Achievement Test Fourth Edition, WRAT-4	Pre-anesthetic to one week Post-anesthetic	Change in WRAT-4

Secondary Outcome Measures

Name	Time	Method
Sport Concussion Assessment Tool - 5th edition, SCAT-5	Pre-anesthetic to one week Post-anesthetic	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).
Oral morphine equivalent of consumed opioids	Post-operatively to hospital discharge, up to 10 days.	Difference of post-operative opioid use between the concussion and non-concussion group
Length of hospital stay	Post-operatively to hospital discharge, up to 30 days.	Difference between the concussion and non-concussion group
Cognitive Deficits identified by NeuroPsychometric Cognitive Testing	Pre-anesthetic to one week Post-anesthetic	Difference between the concussion and non-concussion group.
Numeric Pain Scale 0-10	Post-operatively to hospital discharge, up to 10 days.	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States