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

NCT ID: NCT01584570

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2013-12-23

Brief Summary

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The purpose of this study is to investigate effect of dexmedetomidine and tracheal intubation on heart rate variability and QTc interval.

Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control

fentanyl 1 mcg/kg before induction

Group Type ACTIVE_COMPARATOR

0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min

Intervention Type DRUG

ECG monitoring for evaluation of QTc interval

D 0.5 group

Dexmedetomidine 0.5 ug/kg + Propofol + Sevoflurane+ Vecuronium

Group Type EXPERIMENTAL

0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min

Intervention Type DRUG

ECG monitoring for evaluation of QTc interval

D 1.0 group

Dexmedetomidine 1.0 ug/kg + Propofol + Sevoflurane+ Vecuronium

Group Type EXPERIMENTAL

0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min

Intervention Type DRUG

ECG monitoring for evaluation of QTc interval

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2011-0791

Identifier Type: -

Identifier Source: org_study_id

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