NCT01917786

Brief Summary

Various medications used in anesthesia have been implicated in the prolongation of QT interval. Recently, there has been an increase in the use of dexmedetomidine in patients presenting for surgeries given its beneficial sedative, anxiolytic, and analgesic properties. It has several desirable properties including minimal respiratory side effects as well as the ability to decrease intraoperative and postoperative analgesic requirements. In many of the patients who present for routine surgical procedures, dexmedetomidine is a common component of their anesthetic care. This is a study to assess the effects of dexmedetomidine on the QT interval in children presenting for surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

June 25, 2013

Last Update Submit

January 7, 2016

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • Change in QT interval

    ECG will be done to assess QT interval prior to induction (baseline), after induction (5 mins.) and after dexmedetomidine (10 mins.)

    Baseline, 5 mins., 10 mins.

Study Arms (2)

Dexmedetomidine patients

Surgical patients receiving dexmedetomidine.

Device: ECG

Control patients

Surgical patients not receiving dexmedetomidine.

Device: ECG

Interventions

ECGDEVICE
Control patientsDexmedetomidine patients

Eligibility Criteria

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

Patients receiving dexmedetomidine as part of their surgical anesthesia.

You may qualify if:

  • ASA grade 1 or 2.
  • Scheduled to receive dexmedetomidine.

You may not qualify if:

  • Known allergy to dexmedetomidine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

  • Kako H, Krishna SG, Sebastian R, Smith K, Tobias JD. Effect of dexmedetomidine on the QT interval in pediatric patients undergoing general anesthesia. J Anesth. 2015 Dec;29(6):862-7. doi: 10.1007/s00540-015-2056-2. Epub 2015 Aug 4.

    PMID: 26238761DERIVED

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

June 25, 2013

First Posted

August 7, 2013

Study Start

July 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

US(1)