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

2. februar 2022 opdateret af: Işıl Karabeyoğlu, Ankara City Hospital Bilkent

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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 -

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: sevoflurane
General Anesthesia procedure with sevoflurane
Diagnostisk 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.
Aktiv komparator: desflurane
General Anesthesia procedure with desflurane
Diagnostisk 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
QTc T0
Tidsramme: Baseline, preoperative
QTc; It is calculated by dividing the QT interval by the square root of the RR interval (QTc= QT/ √RR).
Baseline, preoperative
QTc T1
Tidsramme: 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).
During surgery (at the time of the anesthesia induction)
QTc T2
Tidsramme: 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.
During surgery (at the time of MAC reached 0,6)
QTc T3
Tidsramme: 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.
During surgery (at the time of MAC reached1)
QTc T4
Tidsramme: 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.
During surgery (at the time of MAC reached 1,3)
QTc T5
Tidsramme: 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.
During surgery (at the time of MAC reduced 0,3)
iCEB T0
Tidsramme: Baseline, preoperative
Index of cardio-electrophysiological balance (iCEB); calculated as QT distance divided by QRS duration (QT/ QRS)
Baseline, preoperative
iCEB T1
Tidsramme: 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)
During surgery (at the time of the anesthesia induction)
iCEB T2
Tidsramme: 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.
During surgery (at the time of MAC reached 0,6)
iCEB T3
Tidsramme: 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.
During surgery (at the time of MAC reached 1)
iCEB T4
Tidsramme: 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.
During surgery (at the time of MAC reached 1,3)
iCEB T5
Tidsramme: 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.
During surgery (at the time of MAC reduced 0,3)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ankara City Hospital Bilkent

Efterforskere

  • Ledende efterforsker: ışıl karabeyoğlu, Ankara CH bilkent
  • Studiestol: betül güven aytaç, Ankara CH bilkent

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. februar 2022

Primær færdiggørelse (Forventet)

1. maj 2022

Studieafslutning (Forventet)

1. juli 2022

Datoer for studieregistrering

Først indsendt

5. januar 2022

Først indsendt, der opfyldte QC-kriterier

2. februar 2022

Først opslået (Faktiske)

7. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. februar 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • E1-21-2256

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Kliniske forsøg med Sevofluran

Kliniske forsøg med 12- derivation Electrocardiography

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