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

May 20, 2017 updated by: General Hospital of Ningxia Medical University

The Effects of Dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of cardiac troponin I at preoperative, postoperative，and 24 hours after surgery.
Time Frame: 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).
At preoperative, postoperative，and 24 hours after surgery.
Change of Glycogen Phosphorylase Isoenzyme BB at preoperative, postoperative，and 24 hours after surgery.
Time Frame: 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).
At preoperative, postoperative，and 24 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Ningxia Medical University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 20, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 20, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-NW-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

safety

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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