NCT03788564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

December 25, 2018

Last Update Submit

September 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years old
  • scheduled for general anesthesia requiring direct laryngoscopy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2018

First Posted

December 27, 2018

Study Start

September 24, 2017

Primary Completion

May 3, 2020

Study Completion

May 3, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations