Down Syndrome Autonomic Nervous System Induction Bradycardia (DANSIB)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Bradycardia; Down Syndrome

Treatments: Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05120531

R21HL162572 (U.S. NIH Grant/Contract)

2021-0643

Details and patient eligibility

About

Children with Down syndrome (DS) often experience dangerously low heart rates on induction of anesthesia for routine procedures and this occurs at 10 times the rate of non-DS patients. Given that the cardiac output of children is heart rate dependent, bradycardia is especially perilous in this population.

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.

Enrollment: 195 patients

Sex: All

Ages: 1 month to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are overtly healthy as determined by medical evaluation including lack of diagnosis of Down Syndrome and children with Down Syndrome

Exclusion criteria

1. Contraindication to adhesive placement, eg, epidermolysis bullosa
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.

Trial design

195 participants in 2 patient groups

Down Syndrome patients undergoing otolaryngologic surgery with anesthesia

Treatment:

Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia

Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia

Treatment:

Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia