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Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

26. Oktober 2012 aktualisiert von: Xin Chen, Huazhong University of Science and Technology
The investigators hypothesized that dexmedetomidine as an anesthetic adjunct can be used in the setting of off-pump coronary bypass procedure and can provide benefits to cardiac function and cognitive performance on the ground of the dexmedetomidine's characteristics.

Studienübersicht

Status

Unbekannt

Intervention / Behandlung

Detaillierte Beschreibung

The emergence of off-pump coronary artery bypass grafting (OPCAB) procedure brings up new challenges to anesthesiologists and urges us to contemplate the choice of anesthetics. In face of these challenges Dexmedetomdine with multiple unique traits can readily fit into this situation.

Off-pump coronary artery bypass (OPCAB) procedure is an emerging procedure which might bring benefit to patients in comparison with conventional CABGs although final words about outcomes haven't been reached on the basis of recent literature. However, OPCAB technique definitely requires more involvement of anesthesiologists especially in cases where hemodynamic compromise is usually inevitable during anastomosis of Lcx or PDA and early extubation in the OR is expected1. Thus, the investigators are encountered with more intraoperative challenges caused by OPCAB than routine CABGs. Concerning about challenges the investigators might take on, the investigators shall not only pay more attention to surgeons' manipulation but also review anesthetics that the investigators have selected to find an optimal plan to minimize adverse effects on heart and other important organs. With this perspective, dexmedetomidine come into our sight with its peculiar traits of hemodynamic effects and assumed cardiac protective effects.

Dexmedetomidine as a more selective α2-adrenoreceptor agonist than clonidine has gradually gain popularity in anesthetic and ICU settings for its unique pharmacologic characteristics. Dexmedetomidine provides sufficient sedative effects with minimal respiratory effect and then reduces the consumption of other sedative and antinociceptive drugs.Given specific requirements of OPCAB surgery, dexmedetomidine's may be more suitable in varying aspects. Firstly, dexmedetomine can dramatically diminish the level of serum catecholamine (CA). As the investigators know, the diminished level of catecholamine indicates less stress response to surgical stimuli and lower incidence of cardiac events. Secondly, the relatively slower HR by dexmedetomidine can decrease oxygen consumption of myocardium and consequently improve the perfusion of endangered ischemic area. In addition, the decreased HR which is assumably analogous to effects of esmolol or other β-blockers can reduce the occurrence of tachycardia and minimize the motion of heart when "bypass" procedure is performed on the target vessels. Thirdly, it has been reported that dexmedetomidine can alleviate sufferings of renal function during major thoracic surgery .Thus, it is implied that dexmedetomidine might in the similar way ameliorate the damage to renal system caused by hours of stress response and havoc of SIRS ,and then improve clinical prognosis . In view of assumptions the investigators have proposed on the ground of dexmedetomidine's characteristics and specific requirements of OPCAB surgery, the investigators are expecting that dexmdetomidine can fit the situation where patients' limited capacity of coronary artery and sophisticated pathophysiological courses have to be taken into account.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

90

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Hubei
      • Wuhan, Hubei, China, 430030
        • Rekrutierung
        • Department of Anesthesiology ,Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology
        • Hauptermittler:
          • Xin Chen, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

35 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Patients who are planned to undergo off-pump coronary bypass surgery

Beschreibung

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) scores are between classⅡand Ⅲ
  • undergo off-pump coronary artery bypass grafting (OPCAB)

Exclusion Criteria:

  • left ventricular ejection fraction <40%
  • left ventricular aneurysm
  • acute myocardial infarction in latest two weeks
  • atrial fibrillation
  • associated vascular diseases
  • severe systemic diseases involving the renal and hepatic systems
  • respiratory disease( forced vital capacity less than 50% of predicted values ) preoperative left bundle branch block .

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Group High-dose
Dexmedetomidine loading dose 1μg/kg Dexmedetomidine maintenance dose 0.6μg/kg/h
Group Low-dose
Dexmedetomidine loading dose 0.6μg/kg Dexmedetomidine maintenance dose 0.3μg/kg/h
Group Control
Dexmedetomidine loading dose and Dexmedetomidine maintenance dose were placed with the same amount of 0.9% saline as placebo

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI)
Zeitfenster: up to 3 days after the surgery
The parameter measured is dynamic so that it is needed to detect the level at different time points
up to 3 days after the surgery
Hemodynamic values
Zeitfenster: from baseline to the end of the surgery
On the basis of our experience, the period from baseline to the end of the surgery is five hours on average and would depend on the complexity of the surgical procedure
from baseline to the end of the surgery
Serum level of β-amyloid protein
Zeitfenster: up to 3 days after the surgery
The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum. The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.
up to 3 days after the surgery
Serum level of S100 protein
Zeitfenster: up to 3 days after the surgical procedure
The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum. The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.
up to 3 days after the surgical procedure

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS)
Zeitfenster: participants will be followed for the duration of hospital stay, an expected average of4 weeks
The intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) are measured in ICU while the length of hospital stay is recorded at the discharge of every patient.
participants will be followed for the duration of hospital stay, an expected average of4 weeks
Mini-mental state examination(MMSE) scoring
Zeitfenster: up to patients' discharge from hospital
The study is planned to detect the cognitive performance with this commonly used cognitive evaluation scoring
up to patients' discharge from hospital

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2012

Primärer Abschluss (Voraussichtlich)

1. Dezember 2012

Studienabschluss (Voraussichtlich)

1. März 2013

Studienanmeldedaten

Zuerst eingereicht

1. Oktober 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Oktober 2012

Zuerst gepostet (Schätzen)

11. Oktober 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

30. Oktober 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Oktober 2012

Zuletzt verifiziert

1. Oktober 2012

Mehr Informationen

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