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Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft

24. oktober 2014 opdateret af: Hyun Sung Cho, Samsung Medical Center

The Comparison of Antiarrhythmic and Myocardial Protective Effect Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft

The aim of the present study is to compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A previous study has reported that low-dose lidocaine infusion can decrease the incidence of ventricular fibrillation and tachycardia during the first 24 hours after coronary artery bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level.

Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous animal study. However, there was no clinical study evaluating the cardioprotective effect of dexmedetomidine.

Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center

Exclusion Criteria:

  • Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
  • Patients with recent exogenous steroid administration or previous diuretics therapy
  • Patients with recent myocardial infarction
  • Those undergoing unplanned cardiopulmonary bypass during the surgery

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Lidocaine group
a bolus dose of lidocaine 1.5 mg/kg after anesthetic induction with following lidocaine infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
Medicin: Lidocaine infusion
a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
Andre navne:
  • 2% lidocaine hydrochloride
Eksperimentel: Dexmedetomidine group
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
Medicin: Dexmedetomidine infusion
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
Andre navne:
  • Precedex injection
  • Dexmedetomidine hydrochloride 118 mcg/ml
Eksperimentel: Combined infusion group
Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
Medicin: Lidocaine infusion
a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
Andre navne:
  • 2% lidocaine hydrochloride
Medicin: Dexmedetomidine infusion
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
Andre navne:
  • Precedex injection
  • Dexmedetomidine hydrochloride 118 mcg/ml
Ingen indgriben: Control group
The group without infusion of lidocaine or dexmedetomidine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Myocardial injury marker
Tidsramme: postoperative ICU day 1
Myocardial injury marker - CK-MB, and Troponin(i) blood level
postoperative ICU day 1
Myocardial injury marker
Tidsramme: postoperative ICU day 2
Myocardial injury marker - CK-MB, and Troponin(i) blood level
postoperative ICU day 2
Myocardial injury marker
Tidsramme: postoperative ICU day 3
Myocardial injury marker - CK-MB, and Troponin(i) blood level
postoperative ICU day 3

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The blood sodium, potassium, calcium level
Tidsramme: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
The blood sodium, potassium, calcium level
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
The incidence of arrhythmia during and after the surgery
Tidsramme: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3

The incidence of arrhythmia during and after the surgery:

Ventricular premature beat,Atrial premature complex, Bigeminy, Trigeminy, Atrial fibrillation, Ventricular tachycardia, Ventricular fibrillation, Atrio-Ventricular block, PSVT, Junctional rhythm, External pacing
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
Postoperative ICU stay, Hospital stay, Extubation time
Tidsramme: 1 day after hospital discharge
Postoperative ICU stay, Hospital stay
1 day after hospital discharge
Inotropics use during and after the surgery
Tidsramme: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
Inotropics and other drug use during and after the surgery: Dopamine, NTG, dobutamine, milrinone, epinephrine, norepinephrine, amiodarone, diltiazem, remifentanil, esmolol, labetalol, nicardipine, Lasix, phenylephrine, lidocaine, sufentanil
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
The incidence of hypokalemia
Tidsramme: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
The incidence of hypokalemia
1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3

Samarbejdspartnere og efterforskere

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

Sponsor

Samsung Medical Center

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

1. september 2012

Primær færdiggørelse (Faktiske)

1. februar 2013

Studieafslutning (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først indsendt

10. september 2012

Først indsendt, der opfyldte QC-kriterier

16. september 2012

Først opslået (Skøn)

20. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012-07-098-001

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