QT Measurement Techniques and Anesthesia Management

NCT04706104 | Completed

• 1 other identifier: MH2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Long QT Syndrome

Keywords

Cardiac surgery; Index of cardio-electrophysiological balance; Electrocardiography

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  2 minutes after the patients are intubated

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients who will undergo open-heart surgery

You may not qualify if:

• Under the age of 18 years
• Bundle branch block in preoperative ECG
• Arrhythmia in preoperative ECG
• allergies specific to known drugs
• Electrolyte disorders

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 23675554 RESULT

• 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.

  PMID: 11136691 RESULT

• 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.

  PMID: 26305685 RESULT

• 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.

  PMID: 23337247 RESULT

MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aslı Demir, Professor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist in Cardiovascular Anesthesia Department

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 12, 2021
• Study Start: October 10, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

TU (1)