Status:
TERMINATED
Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Down Syndrome
Eligibility:
All Genders
2-17 years
Brief Summary
About 1 in every 700 babies born in the United States has Down's Syndrome (DS; Trisomy 21), 99% of whom have some degree of intellectual disability. Recent advances in medicine have resulted in a dram...
Detailed Description
Based on the Valkenburg group's study (2009), one might hypothesize that if the BIS value is fixed for all patients, then a patient with an intellectual disability such as a patient with DS would requ...
Eligibility Criteria
Inclusion
- • Patients with DS and those without DS receiving BIS monitoring
- Children between the ages of 2 and 17 years old (inclusive)
- Patients scheduled for unilateral or bilateral tympanostomy (ear tube placement) at Penn State Hershey Medical Center
- Patients with American Society of Anesthesiologists (ASA) physical status I, II and III
- Eligible for standard general anesthesia technique protocol as determined by anesthesia provider(s)
Exclusion
- Patients with congenital diseases/anomalies except Down's Syndrome
- Patients with myotonic dystrophies or other neurodegenerative diseases
- Patients with cerebrovascular accidents (strokes)
- Patients not receiving BIS monitoring
- Pregnant patients
- Patients with allergic skin reactions to electrode patches
- Patients 18 years of age and greater
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02288702
Start Date
October 1 2014
End Date
July 13 2017
Last Update
January 23 2023
Active Locations (1)
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1
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033