Down Syndrome Autonomic Nervous System Induction Bradycardia
NCT ID: NCT05120531
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
195 participants
OBSERVATIONAL
2022-01-04
2023-12-12
Brief Summary
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Historically, individuals with DS were not expected to survive beyond childhood; consequently, correction of congenital anomalies, e.g. cardiac defects, was not frequently offered. Fortunately, today individuals with DS live into adulthood and surgical correction of anomalies is universally offered. Thus, increasing numbers of children with DS are exposed to anesthesia and at risk for this hemodynamic catastrophe. It is medically unacceptable and an autonomic nervous system mechanism will be sought.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Down Syndrome patients undergoing otolaryngologic surgery with anesthesia
Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
Use of an Ambulatory Monitoring System from Vuije University (VU-AMS) to record autonomic and cardiovascular activity of patients undergoing otolaryngologic surgery with anesthesia. This monitoring device will provide data of ANS activity and normoxic bradycardia among patients with Down Syndrome. This data will be compared to data from patients without Down Syndrome.
Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia
Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
Use of an Ambulatory Monitoring System from Vuije University (VU-AMS) to record autonomic and cardiovascular activity of patients undergoing otolaryngologic surgery with anesthesia. This monitoring device will provide data of ANS activity and normoxic bradycardia among patients with Down Syndrome. This data will be compared to data from patients without Down Syndrome.
Interventions
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Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
Use of an Ambulatory Monitoring System from Vuije University (VU-AMS) to record autonomic and cardiovascular activity of patients undergoing otolaryngologic surgery with anesthesia. This monitoring device will provide data of ANS activity and normoxic bradycardia among patients with Down Syndrome. This data will be compared to data from patients without Down Syndrome.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patient or parent refusal
3. Opioids
4. Heart rate altering therapy such as beta blockers
5. During the study period, participants will abstain from ingesting caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, and chocolate) for \[6 hours\] before the start of the anesthetic.
6. Participants will be assumed not to be using tobacco or alcohol during the study period due to their young age.
1 Month
8 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Jamie Sinton
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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2021-0643
Identifier Type: -
Identifier Source: org_study_id