免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion
Study Description
Brief Summary:
Researchers are trying to determine if the impact of a concussion on the brain is affected by anesthesia and surgery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Concussion, Brain | Other: Neurocognitive Testing | Not Applicable |
Detailed Description:
All subjects will complete pre and post procedure assessments prior to undergoing a planned surgery/anesthetic standard of care.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion |
| Actual Study Start Date : | February 21, 2019 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Concussion Group
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.
|
Other: Neurocognitive Testing
A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.
|
|
Experimental: Matched Subjects Group
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.
|
Other: Neurocognitive Testing
A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.
|
Outcome Measures
Primary Outcome Measures :
- Wide Range Achievement Test Fourth Edition, WRAT-4 [ Time Frame: Pre-anesthetic to one week Post-anesthetic ]Change in WRAT-4
Secondary Outcome Measures :
- 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.
- 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
- Length of hospital stay [ Time Frame: Post-operatively to hospital discharge, up to 30 days. ]Difference between the concussion and non-concussion group
- Cognitive Deficits identified by NeuroPsychometric Cognitive Testing [ Time Frame: Pre-anesthetic to one week Post-anesthetic ]Difference between the concussion and non-concussion group.
- 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).
Eligibility Criteria
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Contacts
| Contact: Amy L Amsbaugh | 507-538-7538 | amsbaugh.amy@mayo.edu | |
| Contact: Brenda Anderson | 507-255-7157 | anderson.brenda@mayo.edu |
Locations
| United States, Minnesota | |
| Mayo Clinic in Rochester | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Amy L Amsbaugh | |
| Principal Investigator: Arnoley S Abcejo, MD | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Arnoley S Abcejo, MD | Mayo Clinic |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 9, 2019 | ||||||||
| First Posted Date ICMJE | May 16, 2019 | ||||||||
| Last Update Posted Date | August 18, 2020 | ||||||||
| Actual Study Start Date ICMJE | February 21, 2019 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Wide Range Achievement Test Fourth Edition, WRAT-4 [ Time Frame: Pre-anesthetic to one week Post-anesthetic ] Change in WRAT-4
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion | ||||||||
| Official Title ICMJE | Neurocognitive Dysfunction After Anesthesia in Patients With Recent Concussion | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||||||||
| Condition ICMJE | Concussion, Brain | ||||||||
| Intervention ICMJE | Other: Neurocognitive Testing
A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
60 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2022 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03952208 | ||||||||
| Other Study ID Numbers ICMJE | 18-006578 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Arnoley (Arney) S. Abcejo, Mayo Clinic | ||||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | Mayo Clinic | ||||||||
| Verification Date | August 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
