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Completed

NCT Number: NCT03952208

Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion

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

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Key information

Conditions

Concussion, Brain Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurocognitive Testing

Other

A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.

Primary outcomes

  1. Wide Range Achievement Test Fourth Edition, WRAT-4

    Time frame: Pre-anesthetic to one week Post-anesthetic

    Change in WRAT-4

Secondary outcomes

  1. Numeric Pain Scale 0-10

    Time frame: 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.

  2. Oral morphine equivalent of consumed opioids

    Time frame: Post-operatively to hospital discharge, up to 10 days.

    Difference of post-operative opioid use between the concussion and non-concussion group

  3. Length of hospital stay

    Time frame: Post-operatively to hospital discharge, up to 30 days.

    Difference between the concussion and non-concussion group

  4. Cognitive Deficits identified by NeuroPsychometric Cognitive Testing

    Time frame: Pre-anesthetic to one week Post-anesthetic

    Difference between the concussion and non-concussion group.

  5. Sport Concussion Assessment Tool - 5th edition, SCAT-5

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
May 16, 2019
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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