The Effects of Sevoflurane and Desflurane on QT Interval Measured With Cardiac Electrophysiological Balance Index

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sevoflurane; Desflurane; QT Interval; Electrophysiological Balance Index
• Intervention / Treatment: Diagnostic test: 12- derivation Electrocardiography

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: betül güven aytaç; Phone Number: +905073578351; Email: drbguven@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ASA I-II-III risk group
2. the operation time is longer than 1 hour in the Urology department.

Exclusion Criteria:

1. bundle branch block in preoperative ECG,
2. Non-sinus heart rhythm,
3. QT length in preoperative ECG,
4. using drugs that cause known QT prolongation ( beta-blocker drugs using will be included),
5. development of malignant arrhythmia that will disrupt hemodynamics in the intraoperative period,
6. patients with electrolyte disorders,
7. patient refusal -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: sevoflurane; General Anesthesia procedure with sevoflurane	Diagnostic test: 12- derivation Electrocardiography; 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.
Active Comparator: desflurane; General Anesthesia procedure with desflurane	Diagnostic test: 12- derivation Electrocardiography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QTc T0	QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).	Baseline, preoperative
QTc T1	QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).	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.	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.	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.	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.	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)	Baseline, preoperative
iCEB T1	Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS)	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.	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.	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.	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.	During surgery (at the time of MAC reduced 0,3)

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: ışıl karabeyoğlu, Ankara CH bilkent; Study Chair: betül güven aytaç, Ankara CH bilkent

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: E1-21-2256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No