CClinicalTrials.gg
CompletedNCT04706104Updated May 18, 2021

QT Measurement Techniques and Anesthesia Management

An observational study in Long QT Syndrome, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-18.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Long QT Syndrome

Browse trials for

Keywords

  • Cardiac surgery
  • Index of cardio-electrophysiological balance
  • Electrocardiography
03

In context

Long QT Syndrome

95 studies on the registry are indexed under Long QT Syndrome; 20 are open to participants now.

This study's enrollment of 60 is below the median of 150 across 48 observational studies indexed under Long QT Syndrome.

Browse Long QT Syndrome studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Adult patients who will undergo open-heart surgery

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Pre-induction of anesthesia, an average of 5 minutes

  2. 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)

    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

  3. 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)

    Time frame: 2 minutes after the patients are intubated

07

Study locations

1 site
  • Ankara City Hospital
    Ankara, 06800, Turkey
08

References and documents

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 23675554 ↗
  • Schwartz 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 11136691 ↗
  • Robyns 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 26305685 ↗
  • Lu 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04706104
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Eda Balci (Anesthesiologist in Cardiovascular Anesthesia Department, Ankara City Hospital Bilkent) — Principal investigator
First posted
Jan 12, 2021
Start date
Oct 10, 2020
Primary completion
Feb 1, 2021
Completion
Mar 1, 2021
Last update
May 18, 2021

Study contacts

Aslı Demir, Professor
principal investigator · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion