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NCT01880931 Clinical Trial

The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation in Normotensive and Hypertensive Patients

Intubation, Intratracheal Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01880931
Other study ID # 4-2013-0239
Secondary ID
Status Completed
Phase N/A
First received June 16, 2013
Last updated April 8, 2015
Start date June 2013
Est. completion date November 2014

Study information
Verified date April 2015
Source Severance Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients

Description:

It is known that anesthetic agents can influence the QTc. In addition, tracheal intubation during induction can stimulates sympathetic activity, which, as a results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria:

- = 50 years ASA class I-II female who received surgery with endotracheal intubation

Exclusion Criteria:

- emergency surgery electrocardiography abnormality diabetes mellitus end stage renal disease moderate to severe cardiac disease moderate to severe liver dysfunction

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Remifentanil
The effect site concentration of remifentanil

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effect site concentration of remifentanil for preventing QTc interval prolongation 2 min Yes
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