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

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ClinicalTrials.gov Identifier: NCT01704092
Recruitment Status : Unknown
Verified October 2012 by Xin Chen, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : October 11, 2012
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
Xin Chen, Huazhong University of Science and Technology

Brief Summary:
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Drug: Dexmedetomidine

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
Study Start Date : May 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI) [ Time Frame: 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

  2. Hemodynamic values [ Time Frame: 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

  3. Serum level of β-amyloid protein [ Time Frame: 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.

  4. Serum level of S100 protein [ Time Frame: 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.


Secondary Outcome Measures :
  1. intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS) [ Time Frame: 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.

  2. Mini-mental state examination(MMSE) scoring [ Time Frame: up to patients' discharge from hospital ]
    The study is planned to detect the cognitive performance with this commonly used cognitive evaluation scoring


Biospecimen Retention:   Samples With DNA
blood samples are drawn from patients recruited into the study. We planned to draw blood samples from patients with their consent through the central line.


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are planned to undergo off-pump coronary bypass surgery
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704092


Contacts
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Contact: Ailin Luo, professor 13507122565 alluo@tjh.tjmu.edu.cn

Locations
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China, Hubei
Department of Anesthesiology ,Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Principal Investigator: Xin Chen, MD         
Sponsors and Collaborators
Huazhong University of Science and Technology

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Responsible Party: Xin Chen, MD, Principal Investigator, Undergraduate, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01704092     History of Changes
Other Study ID Numbers: 2012001
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action