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

Anesthesia, General Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584570
• Other study ID #: 4-2011-0791
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: December 23, 2013

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 23, 2013
• Est. primary completion date: December 23, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)