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CompletedNCT01917097Updated Oct 27, 2016

Bradycardia Following Intraoperative Administration of Dexmedetomidine

An observational study in Tonsillectomy and Adenotonsillectomy, sponsored by Joseph D. Tobias. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-10-27.

Sponsored by Joseph D. Tobias · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
921
Sex
All
01

Study 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.

02

Conditions studied

  • Tonsillectomy
  • Adenotonsillectomy
03

In context

Lead sponsor

Joseph D. Tobias is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients having ENT surgery at Nationwide Children's Hospital.

Inclusion criteria

  • Patients undergoing adenontonsillectomy or tonsillectomy during 2011 and 2012.

Exclusion criteria

Exclusion Criteria:

  • None.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
921 participants (actual)
Patient registry
No

Groups and cohorts

  • Dexmedetomidine patients

    Patients that received dexmedetomidine during their surgery.

    Drug: Dexmedetomidine

  • No Dexmedetomidine

    Patients that didn't receive dexmedetomidine during surgery.

Interventions

  • DrugDexmedetomidine

    Also known as: Precedex

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What researchers measure

Primary outcomes

  1. Bradycardia

    Time frame: 24 hours

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Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01917097
Lead sponsor
Joseph D. Tobias
Responsible party
Joseph D. Tobias (Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Aug 6, 2013
Start date
Aug 2013
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Oct 27, 2016

Study contacts

Joseph D Tobias, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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