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Effect of Dexmedetomidine on Pacemaker Function Following Cardiac Surgery

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02709200
Enrollment
0
Registered
2016-03-15
Start date
2016-02-29
Completion date
2019-03-11
Last updated
2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Brief summary

This is a prospective study looking at the effects of dexmedetomidine on pacemaker function in patients who have surgery for congenital heart disease utilizing cardiopulmonary bypass (CBP). For the purpose of the study, no change in intraoperative care will be dictated. The use of dexmedetomidine will be left up to the discretion of the treating physicians. The study will involve only the collection of data regarding the amplitude required to capture and specific demographics and intraoperative features including cross clamp time, time on CPB, and vasoactive agents that were and are being administered. In addition to these data, it will be noted whether dexmedetomdine was used or not and whether it is being administered on arrival to the CTICU.

Interventions

DRUGDexmedetomidine

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with temporary surface pacemaker leads following surgery for congenital heart disease.

Exclusion criteria

* Patients with single ventricle anatomy * Patients receiving epinephrine * Infants less than 6 months of age

Design outcomes

Primary

MeasureTime frameDescription
AmplitudeBaselineThe impulse required to elicit atrial or ventricle capture (contraction) of the surface electrode of a temporary postoperative pacemaker.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026