The Effects of Dexmedetomidine and Tracheal Intubation on Heart Rate Variability and QTc Interval

February 25, 2019 updated by: Yonsei University
The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient who are regarded as ASA class I
  • age 20 to 60
  • patient scheduled for Intubation for surgery

Exclusion Criteria:

  • QTc interval > 440 ms
  • arrythmia
  • Patient who is taking a medicine which effects QTc interval
  • HTN
  • DM
  • renal disease
  • hepatic disease
  • pregnant
  • illiterate

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
fentanyl 1 mcg/kg before induction
Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min
ECG monitoring for evaluation of QTc interval
Experimental: D 0.5 group
Dexmedetomidine 0.5 ug/kg + Propofol + Sevoflurane+ Vecuronium
Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min
ECG monitoring for evaluation of QTc interval
Experimental: D 1.0 group
Dexmedetomidine 1.0 ug/kg + Propofol + Sevoflurane+ Vecuronium
Drug: 0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min
ECG monitoring for evaluation of QTc interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of QTc interval
Time Frame: T1 (at rest), T2 (5 min after dexmedetomidine infusion), T3 (just before intubation), T4(1 min after intubation), T5(2 min after intubation), T6(3min after intubation)
T1- baseline, T2- to evaluate the effect of dexmedetomidine on QTc interval, T3- to evaluate QTc interval just before intubation, T4,5,6 - to evaluate QTc interval after intubation
T1 (at rest), T2 (5 min after dexmedetomidine infusion), T3 (just before intubation), T4(1 min after intubation), T5(2 min after intubation), T6(3min after intubation)

Collaborators and Investigators

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

Sponsor

Yonsei University

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

January 1, 2012

Primary Completion (Actual)

December 23, 2013

Study Completion (Actual)

December 23, 2013

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4-2011-0791

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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Locations

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