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NCT02288702 · ClinicalTrials.gov registry record
Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome
A clinical trial, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- 40
- Enrollment target
NCT02288702: Clinical Trial study, sponsored by Milton S. Hershey Medical Center.
NCT02288702 is a clinical trial that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02288702 was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- 40 participants
- Enrollment target
Study 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 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.
Primary Outcome
\>25% lower BIS values in patients with DS compared to patients without DS
Interventions
- DEVICE monitoring BIS in both groups
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-10 |
| Est. Completion | 2017-07-13 |
Why NCT02288702 stopped before completion
NCT02288702 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which monitoring BIS in both groups is the first listed.
NCT02288702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02288702 about?
NCT02288702 is a clinical study titled "Comparison of Bispectral Index Values in Patients With and Without Down's Syndrome". 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 anesthet...
What is the current status of trial NCT02288702?
This trial is currently terminated. The enrollment target is 40 participants. The study started on 2014-10. Estimated completion is 2017-07-13.
What interventions are being tested in trial NCT02288702?
The interventions under investigation include: monitoring BIS in both groups (DEVICE).
Who is sponsoring clinical trial NCT02288702?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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