Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome
Stopped early
Conditions studied: Down Syndrome
In brief
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 dramatically improved lifespan of about 25 to 60 years of age. Yet, there is limited data about anesthetic management in this increasing patient population. The bispectral index (BIS) monitor is a non-invasive monitoring device that reports a value between 0 and 100correlating to level of consciousness of an individual. A value of 0 indicates lack of brain activity while 100 indicates an awake/alert state. This monitor can be used to assess the depth of anesthesia. Patients with intellectual disability from congenital neurological diseases have lower BIS values compared to patients without any neurological impairment (Valkenburg 2009). The results may suggest that DS patients would require less anesthetic drugs compared to patients without any neurological impairment. To date, there are no studies in DS patients.
Key facts
- Study ID
- NCT02288702
- Run by
- Milton S. Hershey Medical Center
- People needed
- 40
- Starts
- 2014-10-01
- Expected to finish
- 2017-07-13
- Last updated by the study team
- 2023-01-23
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- • 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)
You may not qualify if…
- 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
Where it is running
- Hershey Medical Center — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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