Emergence DeliriumNCT03788564
The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
An observational study of Emergence Delirium, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- How many people
- 315 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Sep 2017to 3 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20-65 years old, scheduled for general anesthesia requiring direct laryngoscopy
Who may be able to join
- 20-65 years old
- scheduled for general anesthesia requiring direct laryngoscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 120-752
About this study
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.
- Conditions
- Emergence Delirium
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before anesthesia, Before laryngoscopy, Right after laryngoscopy, 5 minutes after laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start24 Sep 2017
- Primary completion3 May 2020
- Study completion3 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788564
- Sponsor's protocol ID
- 4-2017-0727
- Status last verified
- Sep 2020
- First submitted
- 25 Dec 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT03788564
- Acronym / sponsor ID
- 4-2017-0727
- Conditions
- Emergence Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Sep 2017 (actual)
- Primary completion
- 3 May 2020 (actual)
- Study completion
- 3 May 2020 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20-65 years old, scheduled for general anesthesia requiring direct laryngoscopy
Key inclusion criteria (2 listed)
- 20-65 years old
- scheduled for general anesthesia requiring direct laryngoscopy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QTc interval (time frame: Before anesthesia, Before laryngoscopy, Right after laryngoscopy, 5 minutes after laryngoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.