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

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ClinicalTrials.gov Identifier: NCT03788564
Recruitment Status : Enrolling by invitation
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease
Emergence Delirium

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
Actual Study Start Date : September 24, 2017
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
20-65 years old, scheduled for general anesthesia requiring direct laryngoscopy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788564


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03788564     History of Changes
Other Study ID Numbers: 4-2017-0727
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes