Study Stopped
Unable to enroll subjects.
Effect of Dexmedetomidine on Pacemaker Function Following Cardiac Surgery
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2019
CompletedMarch 28, 2019
March 1, 2019
3.1 years
March 10, 2016
March 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Amplitude
The impulse required to elicit atrial or ventricle capture (contraction) of the surface electrode of a temporary postoperative pacemaker.
Baseline
Study Arms (2)
Dexmedetomidine
Patients that received dexmedetomidine during open heart surgery.
No dexmedetomidine
Patients that didn't receive dexmedetomidine during open heart surgery.
Interventions
Eligibility Criteria
Congenital heart disease patients having open heart surgery.
You may qualify if:
- Patients with temporary surface pacemaker leads following surgery for congenital heart disease.
You may not qualify if:
- Patients with single ventricle anatomy
- Patients receiving epinephrine
- Infants less than 6 months of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Department of Anesthesiology & Pain Medicine
Study Record Dates
First Submitted
March 10, 2016
First Posted
March 15, 2016
Study Start
February 1, 2016
Primary Completion
March 11, 2019
Study Completion
March 11, 2019
Last Updated
March 28, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share