A Study of Assessment of Affect, Behavior, and Cognition in Children Undergoing General Anesthesia
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-006354
Sponsor Protocol Number: 17-006354
About this study
The overall objective of this study is to develop the tools and preliminary data to permit the evaluation of the proposed conceptual framework of how procedures requiring anesthesia affect child health.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Parents of children who are scheduled to receive general anesthesia for elective procedures more than 1 week from the date of review will be contacted by study personnel for recruitment and written informed consent obtained.
- Age 2.5 to 6 at date of recruitment.
- Scheduled to receive general anesthesia for non-cardiac procedures.
- Reside within 50 miles of the city of Rochester.
Exclusion Criteria:
- Preexisting diagnosis of severe developmental delay or neurological impairments.
- Procedures that may significantly affect the function of brain such as brain resection or radiation.
- Anticipated hospitalization > 1 week.
- Children who have injury or surgery to hands that make fine motor testing impossible.
- Children whose parents do not speak English.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Yu Shi, M.D., M.P.H. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available