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The Effects of Dexmedetomidine on cTnI and GP-BB in Patients Undergoing OPCABG

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03163693
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
14.9
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery bypass Grafting.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Dexmedetomidine is a highly selective α2-adrenoceptor agonist used as a sedative or adjuvant anesthetic drug in clinical settings.From clinical observation, dexmedetomidine has been revealed to reduce the incidence of cardiovascular adverse events in patients with heart diseases during non-cardiac surgeries.Therefore, the aim of this sudy is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients during cardiac surgeries.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effects of Dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group dexmedetomidine

20 eligible patients are received 0.5ug/kg dexmedetomidine intravenously 15 minutes before surgery

Drug: dexmedetomidine
receive dexmedetomidine 0.5 μg/kg
Other Names:
  • Dex

    		•
    Placebo Comparator: Group control

    20 eligible patients are received equal volumes normal saline intravenously 15 minutes before surgery

    Other: normal saline
    receive equal volume of normal saline

    Outcome Measures

    Primary Outcome Measures

    1. Change of cardiac troponin I at preoperative, postoperative，and 24 hours after surgery. [At preoperative, postoperative，and 24 hours after surgery.]

      Blood samples were sampled at preoperative, postoperative，and 24 hours after surgery for the cTnI，which were analyzed by using enzyme linked immunosorbent assay (ELISA).

    2. Change of Glycogen Phosphorylase Isoenzyme BB at preoperative, postoperative，and 24 hours after surgery. [At preoperative, postoperative，and 24 hours after surgery.]

      Blood samples were sampled at preoperative, postoperative，and 24 hours after surgery for the GP-BB，which were analyzed by using enzyme linked immunosorbent assay (ELISA).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing off - pump coronary artery bypass grafting

    • ASA physical status III-IV

    • Aged 40-70 years

    • NYHA physical status II-III

    Exclusion Criteria:

    • Bradycardia

    • Atrioventricular block

    • Echocardiography suggested:LVEF <40%, LVED>65mm

    • Allergic to the drugs

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004

    Sponsors and Collaborators

    • General Hospital of Ningxia Medical University

    Investigators

    • Principal Investigator: Zhu Di, General Hospital of Ningxia Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    General Hospital of Ningxia Medical University
    ClinicalTrials.gov Identifier:
    NCT03163693
    Other Study ID Numbers:
    • 2015-NW-028
    First Posted:
    May 23, 2017
    Last Update Posted:
    May 23, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by General Hospital of Ningxia Medical University
    Dexmedetomidine
    Cardiac Troponin I
    Glycogen Phosphorylase Isoenzyme BB
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of May 23, 2017