NCT01584570

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2013

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2 years

First QC Date

April 20, 2012

Last Update Submit

February 25, 2019

Conditions

Anesthesia, General

Keywords

dexmedetomidineheart rate variabilityQTc interval

Outcome Measures

Primary Outcomes (1)

  • Change of QTc interval

    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)

Study Arms (3)

Control

ACTIVE COMPARATOR

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

D 0.5 group

EXPERIMENTAL

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

D 1.0 group

EXPERIMENTAL

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

Interventions

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

ECG monitoring for evaluation of QTc interval

ControlD 0.5 groupD 1.0 group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 25, 2012

Study Start

January 1, 2012

Primary Completion

December 23, 2013

Study Completion

December 23, 2013

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

KR(1)