Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
24 oktober 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
160
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Seoul, Korea, Republiken av, 135-710
- Samsung Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
Andra namn:
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Experimentell: 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
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Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
Andra namn:
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Experimentell: Combined infusion group
Combined lidocaine and dexmedetomidine infusion with the dose specified in single infusion group
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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.
Andra namn:
Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
Andra namn:
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Inget ingripande: Control group
The group without infusion of lidocaine or dexmedetomidine
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Myocardial injury marker
Tidsram: postoperative ICU day 1
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Myocardial injury marker - CK-MB, and Troponin(i) blood level
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postoperative ICU day 1
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Myocardial injury marker
Tidsram: postoperative ICU day 2
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Myocardial injury marker - CK-MB, and Troponin(i) blood level
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postoperative ICU day 2
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Myocardial injury marker
Tidsram: postoperative ICU day 3
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Myocardial injury marker - CK-MB, and Troponin(i) blood level
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postoperative ICU day 3
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The blood sodium, potassium, calcium level
Tidsram: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
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The blood sodium, potassium, calcium level
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1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
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The incidence of arrhythmia during and after the surgery
Tidsram: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, postoperative ICU day 1, 2, 3
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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
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Postoperative ICU stay, Hospital stay, Extubation time
Tidsram: 1 day after hospital discharge
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Postoperative ICU stay, Hospital stay
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1 day after hospital discharge
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Inotropics use during and after the surgery
Tidsram: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
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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
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1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
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The incidence of hypokalemia
Tidsram: 1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
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The incidence of hypokalemia
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1 day before surgery day, at the start of anesthetic induction, 2 hour, 4 hour after anesthetic induction, , postoperative ICU day 1, 2, 3
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2012
Primärt slutförande (Faktisk)
1 februari 2013
Avslutad studie (Faktisk)
1 februari 2013
Studieregistreringsdatum
Först inskickad
10 september 2012
Först inskickad som uppfyllde QC-kriterierna
16 september 2012
Första postat (Uppskatta)
20 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 oktober 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 oktober 2014
Senast verifierad
1 oktober 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Myokardischemi
- Hjärtsjukdom
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Smärta
- Neurologiska manifestationer
- Bröstsmärta
- Angina pectoris
- Arytmier, hjärt
- Angina, instabil
- Läkemedels fysiologiska effekter
- Adrenerga medel
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Medel mot arytmi
- Depressiva medel i centrala nervsystemet
- Agenter från det perifera nervsystemet
- Analgetika
- Sensoriska systemagenter
- Bedövningsmedel
- Analgetika, icke-narkotiska
- Adrenerga alfa-2-receptoragonister
- Adrenerga alfa-agonister
- Adrenerga agonister
- Membrantransportmodulatorer
- Hypnotika och lugnande medel
- Anestesimedel, lokal
- Spänningsstyrda natriumkanalblockerare
- Natriumkanalblockerare
- Dexmedetomidin
- Lidokain
Andra studie-ID-nummer
- 2012-07-098-001
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