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QT Measurement Techniques and Anesthesia Management

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ClinicalTrials.gov Identifier: NCT04706104
Recruitment Status : Completed
First Posted : January 12, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Eda Balci, Ankara City Hospital Bilkent

Tracking Information
First Submitted Date December 30, 2020
First Posted Date January 12, 2021
Last Update Posted Date May 18, 2021
Actual Study Start Date October 10, 2020
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2021)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title QT Measurement Techniques and Anesthesia Management
Official Title Determining the Effects of Two Different Anesthesia Induction Techniques on QT Distance in Cardiac Surgery Patients With Two Different QT Measurement Techniques
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 ( 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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.
Condition Long QT Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 9, 2021)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date March 1, 2021
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

• Adult patients who will undergo open-heart surgery

Exclusion Criteria:

  • Under the age of 18 years
  • Bundle branch block in preoperative ECG
  • Arrhythmia in preoperative ECG
  • allergies specific to known drugs
  • Electrolyte disorders
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04706104
Other Study ID Numbers MH2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Eda Balci, Ankara City Hospital Bilkent
Study Sponsor Ankara City Hospital Bilkent
Collaborators Not Provided
Investigators
Principal Investigator: Aslı Demir, Professor Ankara City Hospital Bilkent
PRS Account Ankara City Hospital Bilkent
Verification Date May 2021