NCT02213718

Brief Summary

This study is to assess the effect of desflurane on myocardial function in patents who underwent 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
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2014

Typical duration for phase_4

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

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 11, 2014

Status Verified

August 1, 2014

Enrollment Period

2.5 years

First QC Date

July 31, 2014

Last Update Submit

August 7, 2014

Conditions

Coronary Artery Bypass Graft RedoGeneral Anesthetic Drug Adverse Reaction

Keywords

Desfluranemyocardial functionCoronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (1)

  • Serum Concentration of cTnI

    at the begingineg of the surgery,immediately after surgery,4 hours after the surgery, 8 hours after the surgery, 12 hours after the surgery, 24 hours after the surgery

    48 hours

Secondary Outcomes (1)

  • Continuous Monitoring of ECG

    participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Other Outcomes (1)

  • Incidence of segmental wall motion

    Incidence of segmental wall motions will be monitored during the surgery, an expected average of 4 hours.

Study Arms (2)

Desflurane

EXPERIMENTAL

desflurane (7%-8% end-tidal concentration), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h)

Drug: DesfluraneDrug: sufentanil

propofol

ACTIVE COMPARATOR

intravenous administration of sufentanil (1μg/kg), etomidate(0.3mg/kg) and vecuronium (0.08mg/kg). The anesthesia is maintained with propofol (TCI:3.5-4.0μg/min), sufentanil (TCI: 2-3 ng/ml) and vecuronium (0.04mg/kg/h).

Drug: propofolDrug: sufentanil

Interventions

DesfluraneDRUG

desflurane (7%-8% end-tidal concentration)

Also known as: brand names：Baxter, serial numbers and code names：not available yet
Desflurane
propofolDRUG

propofol (TCI:3.5-4.0μg/min)

Also known as: brand name：Diprivan, serial numbers and code names：not available yet
propofol
sufentanilDRUG

TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours

Also known as: brand name: Yichang Humanwell pharmaceutical co.,LTD, serial numbers and code names: not available yet
Desfluranepropofol

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Diagnosed with CAD 2. ASAⅡ～Ⅲ

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)

Dept. of Anesthesiolgy, Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Links

MeSH Terms

Interventions

DesfluranePropofolSufentanil

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ailin Luo, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ailin Luo, Doctor

CONTACT

86-13507122565alluo@tjmu.tjh.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
staff

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 11, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

August 11, 2014

Record last verified: 2014-08

Locations

CN(1)