SevofluraneNCT05225779
The Effects of Sevoflurane and Desflurane on QT Interval Measured With Cardiac Electrophysiological Balance Index
A study testing 12- derivation Electrocardiography in people with Sevoflurane and Desflurane, run by Ankara City Hospital Bilkent.
Trial summary
The primary aim of this study is to compare the effects of sevoflurane and desflurane on the QT interval. The secondary aim of this study is to compare the effects of drugs used in the induction and maintenance of anesthesia on the QT interval by calculating the Bazzet formula and iCEB. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sevoflurane, Desflurane, QT Interval
- What is being tested?
- 12- derivation Electrocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Jul 2022
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II-III risk group
- the operation time is longer than 1 hour in the Urology department.
Who cannot join
- bundle branch block in preoperative ECG,
- Non-sinus heart rhythm,
- QT length in preoperative ECG,
- using drugs that cause known QT prolongation ( beta-blocker drugs using will be included),
- development of malignant arrhythmia that will disrupt hemodynamics in the intraoperative period,
- patients with electrolyte disorders,
- patient refusal -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Comparison of the Effects of Sevoflurane and Desflurane Anesthesia on QT Interval Measured With Cardiac Electrophysiological Balance Index
The primary aim of this study is to compare the effects of sevoflurane and desflurane on the QT interval. The secondary aim of this study is to compare the effects of drugs used in the induction and maintenance of anesthesia on the QT interval by calculating the Bazzet formula and iCEB.
- Being tested
- 12- derivation Electrocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12- derivation ElectrocardiographyDiagnostic test
6 precordial and 4 extremity electrodes will be placed at appropriate anatomical points and a total of 6 12-lead ECGs will be taken at different anesthesia depths before anesthesia induction and throughout the operation.
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Active comparator | General Anesthesia procedure with sevoflurane Receives: Diagnostic Test: 12- derivation Electrocardiography |
| desflurane | Active comparator | General Anesthesia procedure with desflurane Receives: Diagnostic Test: 12- derivation Electrocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc T0
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).
Measured: Baseline, preoperative
QTc T1
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).
Measured: During surgery (at the time of the anesthesia induction)
QTc T2
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).When the mac value reaches 0,6, it will be calculated from the ECG.
Measured: During surgery (at the time of MAC reached 0,6)
QTc T3
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).When the mac value reaches 1, it will be calculated from the ECG.
Measured: During surgery (at the time of MAC reached1)
QTc T4
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).When the mac value reaches 1,3 , it will be calculated from the ECG.
Measured: During surgery (at the time of MAC reached 1,3)
QTc T5
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).When the mac value reduces 0,3, it will be calculated from the ECG.
Measured: During surgery (at the time of MAC reduced 0,3)
iCEB T0
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS)
Measured: Baseline, preoperative
iCEB T1
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS)
Measured: During surgery (at the time of the anesthesia induction)
iCEB T2
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) the mac value reaches 0,6, it will be calculated from the ECG.
Measured: During surgery (at the time of MAC reached 0,6)
iCEB T3
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) the mac value reaches 1, it will be calculated from the ECG.
Measured: During surgery (at the time of MAC reached 1)
iCEB T4
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) the mac value reaches 1,3, it will be calculated from the ECG.
Measured: During surgery (at the time of MAC reached 1,3)
iCEB T5
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) when the mac value reduces 0,3, it will be calculated from the ECG.
Measured: During surgery (at the time of MAC reduced 0,3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study startFeb 2022 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SevofluraneStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Işıl Karabeyoğlu, Ankara City Hospital Bilkent
- Investigators
- ışıl karabeyoğlu, Principal investigator, ankara ch bilkentbetül güven aytaç, Study chair, Ankara CH bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225779
- Sponsor's protocol ID
- E1-21-2256
- Status last verified
- Feb 2022
- First submitted
- 5 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of the Effects of Sevoflurane and Desflurane Anesthesia on QT Interval Measured With Cardiac Electrophysiological Balance Index
- ClinicalTrials.gov ID
- NCT05225779
- Acronym / sponsor ID
- E1-21-2256
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 7 Feb 2022 (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 primary aim of this study is to compare the effects of sevoflurane and desflurane on the QT interval. The secondary aim of this study is to compare the effects of drugs used in the induction and maintenance of anesthesia on the QT interval by calculating the Bazzet formula and iCEB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | Active comparator | Diagnostic Test: 12- derivation ElectrocardiographyGeneral Anesthesia procedure with sevoflurane |
| desflurane | Active comparator | Diagnostic Test: 12- derivation ElectrocardiographyGeneral Anesthesia procedure with desflurane |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II-III risk group
- the operation time is longer than 1 hour in the Urology department.
Key exclusion criteria (7 listed)
- bundle branch block in preoperative ECG,
- Non-sinus heart rhythm,
- QT length in preoperative ECG,
- using drugs that cause known QT prolongation ( beta-blocker drugs using will be included),
- development of malignant arrhythmia that will disrupt hemodynamics in the intraoperative period,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12- derivation Electrocardiography6 precordial and 4 extremity electrodes will be placed at appropriate anatomical points and a total of 6 12-lead ECGs will be taken at different anesthesia depths before anesthesia induction and throughout the operation. | Diagnostic test | desflurane, sevoflurane |
Primary outcome
QTc T0
Time frame: Baseline, preoperative
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).
QTc T1
Time frame: During surgery (at the time of the anesthesia induction)
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).
QTc T2
Time frame: During surgery (at the time of MAC reached 0,6)
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).When the mac value reaches 0,6, it will be calculated from the ECG.
QTc T3
Time frame: During surgery (at the time of MAC reached1)
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).When the mac value reaches 1, it will be calculated from the ECG.
QTc T4
Time frame: During surgery (at the time of MAC reached 1,3)
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).When the mac value reaches 1,3 , it will be calculated from the ECG.
QTc T5
Time frame: During surgery (at the time of MAC reduced 0,3)
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).When the mac value reduces 0,3, it will be calculated from the ECG.
iCEB T0
Time frame: Baseline, preoperative
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS)
iCEB T1
Time frame: During surgery (at the time of the anesthesia induction)
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS)
iCEB T2
Time frame: During surgery (at the time of MAC reached 0,6)
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) the mac value reaches 0,6, it will be calculated from the ECG.
iCEB T3
Time frame: During surgery (at the time of MAC reached 1)
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) the mac value reaches 1, it will be calculated from the ECG.
iCEB T4
Time frame: During surgery (at the time of MAC reached 1,3)
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) the mac value reaches 1,3, it will be calculated from the ECG.
iCEB T5
Time frame: During surgery (at the time of MAC reduced 0,3)
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) when the mac value reduces 0,3, it will be calculated from the ECG.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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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.
ışıl karabeyoğlu principal investigator
ankara ch bilkent
betül güven aytaç study chair
Ankara CH bilkent
Questions about this trial
What is this clinical trial studying?
A study testing 12- derivation Electrocardiography in people with Sevoflurane and Desflurane, run by Ankara City Hospital Bilkent.
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 7 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: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact betül güven aytaç (+905073578351, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QTc T0 (time frame: Baseline, preoperative). The study lists 12 primary outcomes in all. 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 7 Feb 2022.