The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation

September 28, 2020 updated by: Yonsei University
The QTc interval is affected by heart rate, medications and changes in the autonomic nervous system. The endotracheal laryngoscopy, the necessary step during general anesthesia, prolongs QTc interval. Changes in the flow of ion currents could result from the genetic variation of myocardial ion channels by gene polymorphism. This study is to investigate the association of cardiac ion channel related gene polymorphism and prolonged QTc interval after endotracheal intubation in adult patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

315

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, 120-752
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy 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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20-65 years old, scheduled for general anesthesia requiring direct laryngoscopy

Description

Inclusion Criteria:

  1. 20-65 years old
  2. scheduled for general anesthesia requiring direct laryngoscopy

Exclusion Criteria:

  1. Patients taking antihypertensive medication (beta-blocker, CCB)
  2. patients taking other medications known to affect QTc interval
  3. Patients with abnormal ECG and prolonged QTc (>500 msec)
  4. Diabetes, liver disease, kidney disease, heart failure, congenital heart disease
  5. Severe electrolyte imbalance
  6. illiterate, foreigners who cannot understand the consent form

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QTc interval
Time Frame: Before anesthesia, Before laryngoscopy, Right after laryngoscopy, 5 minutes after laryngoscopy
QTc interval prolongs followed by laryngoscopy due to changes in the autonomic nervous system. The restoration of the prolonged QTc could also be affected by the balance of autonomic nervous system or changes in the related cardiac ion channels.
Before anesthesia, Before laryngoscopy, Right after laryngoscopy, 5 minutes after laryngoscopy

Collaborators and Investigators

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

Sponsor

Yonsei University

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 (Actual)

September 24, 2017

Primary Completion (Actual)

May 3, 2020

Study Completion (Actual)

May 3, 2020

Study Registration Dates

First Submitted

December 25, 2018

First Submitted That Met QC Criteria

December 25, 2018

First Posted (Actual)

December 27, 2018

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0727

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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