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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03788564
Other study ID # 4-2017-0727
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 24, 2017
Est. completion date May 3, 2020

Study information

Verified date September 2020
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 315
Est. completion date May 3, 2020
Est. primary completion date May 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary QTc interval 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
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