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

NCT05225779 | Unknown

• 1 other identifier: E1-21-2256
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sevoflurane; Desflurane; QT Interval; Electrophysiological Balance Index

Outcome Measures

Primary Outcomes (12)

• 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)

Study Arms (2)

sevoflurane

ACTIVE COMPARATOR

General Anesthesia procedure with sevoflurane

Diagnostic Test: 12- derivation Electrocardiography

desflurane

ACTIVE COMPARATOR

General Anesthesia procedure with desflurane

Diagnostic Test: 12- derivation Electrocardiography

Interventions

12- derivation Electrocardiography DIAGNOSTIC_TEST

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.

desflurane; sevoflurane

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Officials

• ışıl karabeyoğlu

  ankara ch bilkent

  PRINCIPAL INVESTIGATOR

• betül güven aytaç

  Ankara CH bilkent

  STUDY CHAIR

Central Study Contacts

betül güven aytaç

CONTACT

+905073578351; drbguven@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 7, 2022
• Study Start: February 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share