NCT01917097

Brief Summary

This is a retrospective chart review to evaluate the postoperative course of all pediatric patients admitted to the hospital following adenotonsillectomy over the past 24 months to evaluate the incidence of bradycardia in children who received dexmedetomidine intraoperatively and identify confounding factors which may be precipitating the bradycardia or potentiating the negative chronotropic effects of dexmedetomidine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
921

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

August 2, 2013

Last Update Submit

October 26, 2016

Conditions

TonsillectomyAdenotonsillectomy

Outcome Measures

Primary Outcomes (1)

  • Bradycardia

    24 hours

Study Arms (2)

Dexmedetomidine patients

Patients that received dexmedetomidine during their surgery.

Drug: Dexmedetomidine

No Dexmedetomidine

Patients that didn't receive dexmedetomidine during surgery.

Interventions

DexmedetomidineDRUG
Also known as: Precedex
Dexmedetomidine patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having ENT surgery at Nationwide Children's Hospital.

You may qualify if:

  • Patients undergoing adenontonsillectomy or tonsillectomy during 2011 and 2012.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joseph D Tobias, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 6, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(1)