The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients

This study is currently recruiting participants.

Verified November 2012 by Severance Hospital

Sponsor:

Information provided by (Responsible Party):

So Yeon Kim, Severance Hospital

ClinicalTrials.gov Identifier:

NCT01720498

First received: October 31, 2012

Last updated: November 2, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 31, 2012

Last Updated Date

November 2, 2012

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The effect site concentration for preventing QTc interval prolongation [ Time Frame: 2 min ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01720498 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients

Official Title ^ICMJE

Not Provided

Brief Summary

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

Detailed Description

The increase of Corrected QT (QTc) interval is associated with age. It is known that most inhalation anesthetics or intravenous anesthetics 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 elderly patients.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

General Surgery With Endotracheal Intubation

Intervention ^ICMJE

Drug: remifentanil

The effect site concentration of remifentanil

Study Arm (s)

Experimental: Male
To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method

Intervention: Drug: remifentanil
Experimental: Female
To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method

Intervention: Drug: remifentanil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

≥ 65 years ASA class I-II who received surgery with endotracheal intubation

Exclusion Criteria:

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: So Yeon Kim, MD, PhD

82-2-2227-4470

KIMSY326@yuhs.ac

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01720498

Other Study ID Numbers ^ICMJE

4-2012-0581

Has Data Monitoring Committee

Responsible Party

So Yeon Kim, Severance Hospital

Study Sponsor ^ICMJE

Severance Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

So Yeon Kim, MD, PhD

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Information Provided By

Severance Hospital

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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