Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04706104
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2020-12-30
Brief Title:
QT Measurement Techniques and Anesthesia Management
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Determining the Effects of Two Different Anesthesia Induction Techniques on QT Distance in Cardiac Surgery Patients With Two Different QT Measurement Techniques
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 34 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 mgkg propofol and 1-2 mgkg ketamine will be used for anesthesia induction in the first group 015 mgkg midazolam and 10-15 mcgkg 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
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 34 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 mgkg propofol and 1-2 mgkg ketamine will be used for anesthesia induction in the first group 015 mgkg midazolam and 10-15 mcgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None