Effect of Dexmedetomidine on QT Interval in Pediatric Patients Under General Anesthesia

January 7, 2016 updated by: Senthil G. Krishna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving dexmedetomidine as part of their surgical anesthesia.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Known allergy to dexmedetomidine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dexmedetomidine patients
Surgical patients receiving dexmedetomidine.
Device: ECG
Control patients
Surgical patients not receiving dexmedetomidine.
Device: ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QT interval
Time Frame: Baseline, 5 mins., 10 mins.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senthil G. Krishna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • IRB13-00171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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