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NCT02709200 Clinical Trial

Effect of Dexmedetomidine on Pacemaker Function Following Cardiac Surgery

Congenital Heart Disease Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02709200
Other study ID # IRB13-00127
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date February 2016
Est. completion date March 11, 2019

Study information
Verified date March 2019
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 11, 2019
Est. primary completion date March 11, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Months and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amplitude The impulse required to elicit atrial or ventricle capture (contraction) of the surface electrode of a temporary postoperative pacemaker. Baseline
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