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

• Sponsor: Ankara City Hospital Bilkent (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05225779
• Collaborator: (none)
• Enrollment: 120
• Arms: 2
• Anticipated Duration (Months): 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sevoflurane; Desflurane; QT Interval; Electrophysiological Balance Index	Diagnostic Test: 12- derivation Electrocardiography	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Prospective Randomized Comparison of the Effects of Sevoflurane and Desflurane Anesthesia on QT Interval Measured With Cardiac Electrophysiological Balance Index
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. QTc T0 [Baseline, preoperative]

   QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).

2. QTc T1 [During surgery (at the time of the anesthesia induction)]

   QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).

3. QTc T2 [During surgery (at the time of MAC reached 0,6)]

   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.

4. QTc T3 [During surgery (at the time of MAC reached1)]

   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.

5. QTc T4 [During surgery (at the time of MAC reached 1,3)]

   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.

6. QTc T5 [During surgery (at the time of MAC reduced 0,3)]

   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.

7. iCEB T0 [Baseline, preoperative]

   Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS)

8. iCEB T1 [During surgery (at the time of the anesthesia induction)]

   Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS)

9. iCEB T2 [During surgery (at the time of MAC reached 0,6)]

   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.

10. iCEB T3 [During surgery (at the time of MAC reached 1)]

    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.

11. iCEB T4 [During surgery (at the time of MAC reached 1,3)]

    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.

12. iCEB T5 [During surgery (at the time of MAC reduced 0,3)]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ankara City Hospital Bilkent

Investigators

• Principal Investigator: ışıl karabeyoğlu, ankara ch bilkent
• Study Chair: betül güven aytaç, Ankara CH bilkent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Işıl Karabeyoğlu, principal investigator, Ankara City Hospital Bilkent
• ClinicalTrials.gov Identifier: NCT05225779
• Other Study ID Numbers: E1-21-2256
• First Posted: Feb 7, 2022
• Last Update Posted: Feb 7, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 7, 2022