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

April 8, 2015 updated by: So Yeon Kim, Severance Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normotensive patients
To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method
Drug: Remifentanil
The effect site concentration of remifentanil
Experimental: Hypertensive patients
To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method
Drug: Remifentanil
The effect site concentration of remifentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect site concentration of remifentanil for preventing QTc interval prolongation
Time Frame: 2 min
2 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Investigators

  • Principal Investigator: So Yeon Kim, MD, PhD, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

June 16, 2013

First Submitted That Met QC Criteria

June 16, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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