NCT03163693

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

May 15, 2017

Last Update Submit

May 20, 2017

Conditions

Coronary Artery Bypass, Off-Pump

Keywords

DexmedetomidineCardiac Troponin IGlycogen Phosphorylase Isoenzyme BB

Outcome Measures

Primary Outcomes (2)

  • Change of cardiac troponin I 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.

    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.

Study Arms (2)

Group dexmedetomidine

EXPERIMENTAL

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

Drug: dexmedetomidine

Group control

PLACEBO COMPARATOR

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

Other: normal saline

Interventions

dexmedetomidineDRUG

receive dexmedetomidine 0.5 μg/kg

Also known as: Dex
Group dexmedetomidine
normal salineOTHER

receive equal volume of normal saline

Group control

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing off - pump coronary artery bypass grafting
  • ASA physical status III-IV
  • Aged 40-70 years
  • NYHA physical status II-III

You may not qualify if:

  • Bradycardia
  • Atrioventricular block
  • Echocardiography suggested:LVEF \<40%, LVED\>65mm
  • Allergic to the drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated, 1FF

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Zhu Di

    General Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 23, 2017

Study Start

February 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

safety

Locations

CN(1)