Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 2/6/2019 |
| Start Date: | October 2014 |
| End Date: | February 2020 |
| Contact: | Diane McCloskey |
| Email: | dmccloskey@pennstathealth.psu.edu |
| Phone: | 717-531-0003 |
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.
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.
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 require less anesthetic drugs compared to a control patient without any neurological
disability. However, if one is only using a clinical sedation scale, the DS patient may
receive more anesthetic drugs in order to achieve the same level of clinical unconsciousness
as a patient without DS.
This project seeks to elucidate the effect of anesthetic techniques and agents on patients
with DS compared to those without DS and any intellectual disability. The goal of this
project is to compare BIS values in patients with DS to those without DS undergoing a
standardized general anesthetic technique. The investigators hypothesize that patients with
DS would have lower (>25%) BIS values compared to those without DS.
Known potential sources of artifact signals that could change BIS values include
electromyographic activity, electric devices, hypothermia, hypoglycemia, and the timing and
type of anesthetics used (Duarte 2009, Dahaba 2005). These potential sources will be
identified and reported during the study, and those patients will be excluded from the study
fixed for all patients, then a patient with an intellectual disability such as a patient with
DS would require less anesthetic drugs compared to a control patient without any neurological
disability. However, if one is only using a clinical sedation scale, the DS patient may
receive more anesthetic drugs in order to achieve the same level of clinical unconsciousness
as a patient without DS.
This project seeks to elucidate the effect of anesthetic techniques and agents on patients
with DS compared to those without DS and any intellectual disability. The goal of this
project is to compare BIS values in patients with DS to those without DS undergoing a
standardized general anesthetic technique. The investigators hypothesize that patients with
DS would have lower (>25%) BIS values compared to those without DS.
Known potential sources of artifact signals that could change BIS values include
electromyographic activity, electric devices, hypothermia, hypoglycemia, and the timing and
type of anesthetics used (Duarte 2009, Dahaba 2005). These potential sources will be
identified and reported during the study, and those patients will be excluded from the study
Inclusion Criteria:
- • 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 Criteria:
- 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
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