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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05225779
Other study ID # E1-21-2256
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2022
Est. completion date July 2022

Study information

Verified date February 2022
Source Ankara City Hospital Bilkent
Contact betül güven aytaç
Phone +905073578351
Email drbguven@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date July 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Outcome

Type Measure Description Time frame Safety issue
Primary QTc T0 QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ vRR). Baseline, preoperative
Primary QTc T1 QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ vRR). During surgery (at the time of the anesthesia induction)
Primary QTc T2 QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ vRR).When the mac value reaches 0,6, it will be calculated from the ECG. During surgery (at the time of MAC reached 0,6)
Primary QTc T3 QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ vRR).When the mac value reaches 1, it will be calculated from the ECG. During surgery (at the time of MAC reached1)
Primary QTc T4 QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ vRR).When the mac value reaches 1,3 , it will be calculated from the ECG. During surgery (at the time of MAC reached 1,3)
Primary QTc T5 QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ vRR).When the mac value reduces 0,3, it will be calculated from the ECG. During surgery (at the time of MAC reduced 0,3)
Primary iCEB T0 Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS) Baseline, preoperative
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
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