NCT01704092

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.

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

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

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

October 1, 2012

Last Update Submit

October 26, 2012

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

  • cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI)

    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

    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

    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

    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

Secondary Outcomes (2)

  • intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS)

    participants will be followed for the duration of hospital stay, an expected average of4 weeks

  • Mini-mental state examination(MMSE) scoring

    up to patients' discharge from hospital

Study Arms (3)

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

Interventions

DexmedetomidineDRUG
Group ControlGroup High-doseGroup Low-dose

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology ,Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

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.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Ailin Luo, professor

CONTACT

13507122565alluo@tjh.tjmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator, Undergraduate

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 11, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

CN(1)