Long QT SyndromeNCT04706104
QT Measurement Techniques and Anesthesia Management
An observational study of Long QT Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In studies, the effects of drugs used for anesthesia and analgesia on QT distance were evaluated in isolation. However, drugs are administered in combination with each other during anesthesia induction. Therefore, drugs interact in terms of positive and undesirable effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long QT Syndrome
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2020to 1 Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 60 adult patients in both groups who will undergo open heart surgery will be included in the study. Using the randomization program, the patients will be divided into two groups of 30 people. While 2-3 mg / kg propofol and 1-2 mg / kg ketamine will be used for anesthesia induction in the first group, 0.15 mg / kg midazolam and 10-15 mcg / kg fentanyl will be used for anesthesia induction in the other group.
Who may be able to join
- Adult patients who will undergo open-heart surgery
Who cannot join
- Under the age of 18 years
- Bundle branch block in preoperative ECG
- Arrhythmia in preoperative ECG
- allergies specific to known drugs
- Electrolyte disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effects of Two Different Anesthesia Induction Techniques on QT Distance in Cardiac Surgery Patients With Two Different QT Measurement Techniques
In studies, the effects of drugs used for anesthesia and analgesia on QT distance were evaluated in isolation. However, drugs are administered in combination with each other during anesthesia induction. Therefore, drugs interact in terms of positive and undesirable effects. In addition, most of the studies examining anesthesia and QT distance have been conducted in non-cardiac surgery. The target group in this study is the adult patient group who will undergo cardiac surgery. The primary aim of our study is to investigate the effect of two different types of anesthesia induction techniques on QT distance in patients undergoing open-heart surgery. QT evaluation will be performed after endotracheal intubation after anesthesia induction.
Read the detailed description
Long QT syndrome (LQTS) is a cardiac conduction disorder characterized by the prolongation and extension of ventricular repolarization. This prolonged repolarization may cause re-entry circuits when sympathetic activity is added and may cause syncope, dizziness, torsades de pointes (TdP), ventricular fibrillation (VF), ventricular tachycardia (VT), or sudden cardiac death (1). LQTS is divided into two groups as congenital and acquired. Drug-induced LQTS is the most common cause of the acquired form. It is known that some drugs used during anesthesia and analgesia management have effects on the QT distance (2).
The QT interval is the most commonly used ECG indicator for arrhythmias, representing the action potential duration (3). The prolonged QT interval is a risk marker frequently used in patients with a predisposition to the development of TdP, a type of polymorphic VT or VF variant. Often the QT distance is computed with the corrected QT (QTc) Bazett formula (QTc = QT / √RR). However, non-torsadogenic VT / VF cannot be evaluated with QTc alone, and this has led to the need for new additional biomarkers.
A new marker called "Index of cardio-electrophysiological balance (iCEB)" shows the balance between depolarization and repolarization of the action potential. The iCEB calculated by dividing the QT interval by the QRS duration (QT / QRS); In addition to drug-induced long QT and TdP, it is also superior in detecting conduction slowdowns, QT shortening, and associated non-TdP-like VT / VF induced by drugs, especially drugs used in anesthesia management, and is now shown as a potential risk predictor in drug-induced arrhythmias ( 3,4). The secondary aim of our study is to evaluate the effects of drugs used in anesthesia management on QT distance with Bazett and iCEB techniques.
The expected benefit from the research is to determine the effects of two different anesthesia induction techniques, in which anesthetic drugs are applied in combination, on the QT prolongation induced by drugs, and to detect QT prolongations in different periods of anesthesia with different QT measurement methods. No study-specific risk is considered.
This study was planned prospectively and randomized. If the patients who will undergo open-heart surgery in the cardiovascular surgery operating rooms are evaluated in terms of both anesthesia methods after the preoperative routine evaluation and meet the conditions for participation in the study, the research project will be explained to the patients. If accepted by the patients, verbal and written consent will be obtained and the patients will be included in the study. Anesthesia management and grouping will be determined by the randomization program.
A total of 60 adult patients in both groups who will undergo open-heart surgery will be included in the study. Using the randomization program, the patients will be divided into two groups of 30 people. While 2-3 mg/kg propofol and 1-2 mg/kg ketamine will be used for anesthesia induction in the first group, 0.15 mg/kg midazolam and 10-15 mcg/kg fentanyl will be used for anesthesia induction in the other group. Patients with bundle branch block in their preoperative ECG, patients with arrhythmia, allergies specific to known drugs, and patients with electrolyte disorders will not be included in the study.
Age, gender, body weight, and height of the patients will be recorded. Patients will be questioned in terms of additional diseases and medicines they use. Preoperative blood sodium, potassium, and calcium values will be evaluated and recorded in terms of electrolyte imbalance.
Patients will be taken to the operation room and rested for 1 minute by preoxygenation. Then, 12-lead ECG will be taken to evaluate the QT length with the Bazett formula (QTc = QT / √RR) and the iCEB formula (QT / QRS), and the average arterial pressure, heart rate, oxygen saturation of the patient will be recorded simultaneously. ECG measurements will be analyzed on lead II and lead V5.
Afterward, the same parameters will be re-recorded after the completion of anesthesia induction suitable for the groups and the bispectral index value falls below the BIS value of 40.
Third and lastly, the same parameters will be recorded 2 minutes after the patients are intubated.
- Conditions
- Long QT Syndrome
- Keywords
- Cardiac surgery, Index of cardio-electrophysiological balance, Electrocardiography
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Propofol-Ketamine | 2-3 mg/kg propofol and 1-2 mg/kg ketamine will be used for anesthesia induction | |
| Midazolam-Fentanyl | 0.15 mg/kg midazolam and 10-15 mcg/kg fentanyl will be used for anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT distance- baseline- pre-induction of anesthesia
12-lead ECG will be taken to evaluate the QT distance with the Bazett formula (QTc = QT / √RR) and the iCEB formula (QT / QRS)
Measured: Pre-induction of anesthesia, an average of 5 minutes
QT distance- post-induction of anesthesia
12-lead ECG will be taken to evaluate the QT distance with the Bazett formula (QTc = QT / √RR) and the iCEB formula (QT / QRS)
Measured: After the completion of anesthesia induction suitable for the groups and the bispectral index value falls below the BIS value of 40, an average of 5 minutes
QT distance- after intubation
12-lead ECG will be taken to evaluate the QT distance with the Bazett formula (QTc = QT / √RR) and the iCEB formula (QT / QRS)
Measured: 2 minutes after the patients are intubated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start10 Oct 2020
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Long QT SyndromeStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Balci, Ankara City Hospital Bilkent
- Investigators
- Aslı Demir, Professor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706104
- Sponsor's protocol ID
- MH2
- Status last verified
- May 2021
- First submitted
- 30 Dec 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fazio G, Vernuccio F, Grutta G, Re GL. Drugs to be avoided in patients with long QT syndrome: Focus on the anaesthesiological management. World J Cardiol. 2013 Apr 26;5(4):87-93. doi: 10.4330/wjc.v5.i4.87.
PubMed 23675554Schwartz PJ, Priori SG, Spazzolini C, Moss AJ, Vincent GM, Napolitano C, Denjoy I, Guicheney P, Breithardt G, Keating MT, Towbin JA, Beggs AH, Brink P, Wilde AA, Toivonen L, Zareba W, Robinson JL, Timothy KW, Corfield V, Wattanasirichaigoon D, Corbett C, Haverkamp W, Schulze-Bahr E, Lehmann MH, Schwartz K, Coumel P, Bloise R. Genotype-phenotype correlation in the long-QT syndrome: gene-specific triggers for life-threatening arrhythmias. Circulation. 2001 Jan 2;103(1):89-95. doi: 10.1161/01.cir.103.1.89.
PubMed 11136691Robyns T, Lu HR, Gallacher DJ, Garweg C, Ector J, Willems R, Janssens S, Nuyens D. Evaluation of Index of Cardio-Electrophysiological Balance (iCEB) as a New Biomarker for the Identification of Patients at Increased Arrhythmic Risk. Ann Noninvasive Electrocardiol. 2016 May;21(3):294-304. doi: 10.1111/anec.12309. Epub 2015 Aug 25.
PubMed 26305685Lu HR, Yan GX, Gallacher DJ. A new biomarker--index of cardiac electrophysiological balance (iCEB)--plays an important role in drug-induced cardiac arrhythmias: beyond QT-prolongation and Torsades de Pointes (TdPs). J Pharmacol Toxicol Methods. 2013 Sep-Oct;68(2):250-259. doi: 10.1016/j.vascn.2013.01.003. Epub 2013 Jan 19.
PubMed 23337247
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effects of Two Different Anesthesia Induction Techniques on QT Distance in Cardiac Surgery Patients With Two Different QT Measurement Techniques
- ClinicalTrials.gov ID
- NCT04706104
- Acronym / sponsor ID
- MH2
- Conditions
- Long QT Syndrome
- Keywords
- Cardiac surgery, Index of cardio-electrophysiological balance, Electrocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 12 Jan 2021 (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.
In studies, the effects of drugs used for anesthesia and analgesia on QT distance were evaluated in isolation. However, drugs are administered in combination with each other during anesthesia induction. Therefore, drugs interact in terms of positive and undesirable effects. In addition, most of the studies examining anesthesia and QT distance have been conducted in non-cardiac surgery. The target group in this study is the adult patient group who will undergo cardiac surgery. The primary aim of our study is to investigate the effect of two different types of anesthesia induction techniques on QT distance in patients undergoing open-heart surgery. QT evaluation will be performed after endotracheal intubation after anesthesia induction.
Detailed description
Long QT syndrome (LQTS) is a cardiac conduction disorder characterized by the prolongation and extension of ventricular repolarization. This prolonged repolarization may cause re-entry circuits when sympathetic activity is added and may cause syncope, dizziness, torsades de pointes (TdP), ventricular fibrillation (VF), ventricular tachycardia (VT), or sudden cardiac death (1). LQTS is divided into two groups as congenital and acquired. Drug-induced LQTS is the most common cause of the acquired form. It is known that some drugs used during anesthesia and analgesia management have effects on the QT distance (2).
The QT interval is the most commonly used ECG indicator for arrhythmias, representing the action potential duration (3). The prolonged QT interval is a risk marker frequently used in patients with a predisposition to the development of TdP, a type of polymorphic VT or VF variant. Often the QT distance is computed with the corrected QT (QTc) Bazett formula (QTc = QT / √RR). However, non-torsadogenic VT / VF cannot be evaluated with QTc alone, and this has led to the need for new additional biomarkers.
A new marker called "Index of cardio-electrophysiological balance (iCEB)" shows the balance between depolarization and repolarization of the action potential. The iCEB calculated by dividing the QT interval by the QRS duration (QT / QRS); In addition to drug-induced long QT and TdP, it is also superior in detecting conduction slowdowns, QT shortening, and associated non-TdP-like VT / VF induced by drugs, especially drugs used in anesthesia management, and is now shown as a potential risk predictor in drug-induced arrhythmias ( 3,4). The secondary aim of our study is to evaluate the effects of drugs used in anesthesia management on QT distance with Bazett and iCEB techniques.
The expected benefit from the research is to determine the effects of two different anesthesia induction techniques, in which anesthetic drugs are applied in combination, on the QT prolongation induced by drugs, and to detect QT prolongations in different periods of anesthesia with different QT measurement methods. No study-specific risk is considered.
This study was planned prospectively and randomized. If the patients who will undergo open-heart surgery in the cardiovascular surgery operating rooms are evaluated in terms of both anesthesia methods after the preoperative routine evaluation and meet the conditions for participation in the study, the research project will be explained to the patients. If accepted by the patients, verbal and written consent will be obtained and the patients will be included in the study. Anesthesia management and grouping will be determined by the randomization program.
A total of 60 adult patients in both groups who will undergo open-heart surgery will be included in the study. Using the randomization program, the patients will be divided into two groups of 30 people. While 2-3 mg/kg propofol and 1-2 mg/kg ketamine will be used for anesthesia induction in the first group, 0.15 mg/kg midazolam and 10-15 mcg/kg fentanyl will be used for anesthesia induction in the other group. Patients with bundle branch block in their preoperative ECG, patients with arrhythmia, allergies specific to known drugs, and patients with electrolyte disorders will not be included in the study.
Age, gender, body weight, and height of the patients will be recorded. Patients will be questioned in terms of additional diseases and medicines they use. Preoperative blood sodium, potassium, and calcium values will be evaluated and recorded in terms of electrolyte imbalance.
Patients will be taken to the operation room and rested for 1 minute by preoxygenation. Then, 12-lead ECG will be taken to evaluate the QT length with the Bazett formula (QTc = QT / √RR) and the iCEB formula (QT / QRS), and the average arterial pressure, heart rate, oxygen saturation of the patient will be recorded simultaneously. ECG measurements will be analyzed on lead II and lead V5.
Afterward, the same parameters will be re-recorded after the completion of anesthesia induction suitable for the groups and the bispectral index value falls below the BIS value of 40.
Third and lastly, the same parameters will be recorded 2 minutes after the patients are intubated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol-Ketamine | – | –2-3 mg/kg propofol and 1-2 mg/kg ketamine will be used for anesthesia induction |
| Midazolam-Fentanyl | – | –0.15 mg/kg midazolam and 10-15 mcg/kg fentanyl will be used for anesthesia induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 adult patients in both groups who will undergo open heart surgery will be included in the study. Using the randomization program, the patients will be divided into two groups of 30 people. While 2-3 mg / kg propofol and 1-2 mg / kg ketamine will be used for anesthesia induction in the first group, 0.15 mg / kg midazolam and 10-15 mcg / kg fentanyl will be used for anesthesia induction in the other group.
Key inclusion criteria (1 listed)
- Adult patients who will undergo open-heart surgery
Key exclusion criteria (5 listed)
- Under the age of 18 years
- Bundle branch block in preoperative ECG
- Arrhythmia in preoperative ECG
- allergies specific to known drugs
- Electrolyte disorders
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
QT distance- baseline- pre-induction of anesthesia
Time frame: Pre-induction of anesthesia, an average of 5 minutes
12-lead ECG will be taken to evaluate the QT distance with the Bazett formula (QTc = QT / √RR) and the iCEB formula (QT / QRS)
QT distance- post-induction of anesthesia
Time frame: After the completion of anesthesia induction suitable for the groups and the bispectral index value falls below the BIS value of 40, an average of 5 minutes
12-lead ECG will be taken to evaluate the QT distance with the Bazett formula (QTc = QT / √RR) and the iCEB formula (QT / QRS)
QT distance- after intubation
Time frame: 2 minutes after the patients are intubated
12-lead ECG will be taken to evaluate the QT distance with the Bazett formula (QTc = QT / √RR) and the iCEB formula (QT / QRS)
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 18 May 2021.
- Results publication: PubMed 23675554Fazio G, Vernuccio F, Grutta G, Re GL. Drugs to be avoided in patients with long QT syndrome: Focus on the anaesthesiological management. World J Cardiol. 2013 Apr 26;5(4):87-93. doi: 10.4330/wjc.v5.i4.87.
- Results publication: PubMed 11136691Schwartz PJ, Priori SG, Spazzolini C, Moss AJ, Vincent GM, Napolitano C, Denjoy I, Guicheney P, Breithardt G, Keating MT, Towbin JA, Beggs AH, Brink P, Wilde AA, Toivonen L, Zareba W, Robinson JL, Timothy KW, Corfield V, Wattanasirichaigoon D, Corbett C, Haverkamp W, Schulze-Bahr E, Lehmann MH, Schwartz K, Coumel P, Bloise R. Genotype-phenotype correlation in the long-QT syndrome: gene-specific triggers for life-threatening arrhythmias. Circulation. 2001 Jan 2;103(1):89-95. doi: 10.1161/01.cir.103.1.89.
- Results publication: PubMed 26305685Robyns T, Lu HR, Gallacher DJ, Garweg C, Ector J, Willems R, Janssens S, Nuyens D. Evaluation of Index of Cardio-Electrophysiological Balance (iCEB) as a New Biomarker for the Identification of Patients at Increased Arrhythmic Risk. Ann Noninvasive Electrocardiol. 2016 May;21(3):294-304. doi: 10.1111/anec.12309. Epub 2015 Aug 25.
- Results publication: PubMed 23337247Lu HR, Yan GX, Gallacher DJ. A new biomarker--index of cardiac electrophysiological balance (iCEB)--plays an important role in drug-induced cardiac arrhythmias: beyond QT-prolongation and Torsades de Pointes (TdPs). J Pharmacol Toxicol Methods. 2013 Sep-Oct;68(2):250-259. doi: 10.1016/j.vascn.2013.01.003. Epub 2013 Jan 19.
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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.
Aslı Demir, Professor principal investigator
Ankara City Hospital Bilkent
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 Long QT Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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 18 May 2021. 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 Turkey (Türkiye). 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?
QT distance- baseline- pre-induction of anesthesia (time frame: Pre-induction of anesthesia, an average of 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04706104, which also lists 4 linked publications.
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 18 May 2021.