Bradycardia Following Intraoperative Administration of De... | NCT01917097

Studies
Bradycardia Following Intraoperative Administration of Dexmedetomidine

NCT01917097

Sponsor

Joseph D. Tobias

Status

Completed

Last Update Posted

Oct 27, 2016Estimated

Enrollment

921Actual

Phase

Not provided

Conditions

Tonsillectomy
Adenotonsillectomy

Interventions

Dexmedetomidine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Aug 2, 2013

First Submission Date that Met QC Criteria

Aug 2, 2013

First Posted Date

Aug 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Joseph D. TobiasOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

921Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexmedetomidine patients		Patients that received dexmedetomidine during their surgery.	Drug: Dexmedetomidine
No Dexmedetomidine		Patients that didn't receive dexmedetomidine during surgery.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug		Dexmedetomidine patients	Precedex

Measure	Description	Time Frame
Bradycardia		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing adenontonsillectomy or tonsillectomy during 2011 and 2012.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients having ENT surgery at Nationwide Children's Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph D Tobias, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided