NCT01461551

Brief Summary

Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

November 20, 2014

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

October 19, 2011

Results QC Date

November 5, 2014

Last Update Submit

May 6, 2015

Conditions

Anesthesia

Keywords

troponin Icreatine kinase mbhospital dayslymphocyte apoptosisintensive care unit days

Outcome Measures

Primary Outcomes (1)

  • Lymphocyte Count

    Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.

    1 day after surgery

Secondary Outcomes (1)

  • Intensive Care Unit Staying Days

    participants will stay in intensive care unit after surgery, an expected average of 2 days

Study Arms (3)

Sevoflurane

EXPERIMENTAL
Drug: Sevoflurane

Propofol

EXPERIMENTAL
Drug: Propofol

Combine of sevoflurane and propofol

EXPERIMENTAL
Drug: combine of sevoflurane and propofol

Interventions

SevofluraneDRUG

anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)

Sevoflurane
PropofolDRUG

anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)

Propofol
combine of sevoflurane and propofolDRUG

anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)

Combine of sevoflurane and propofol

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male adults
  • aged 18-80 yr
  • undergoing elective OPCAB surgery containing left anterior descending artery bypass

You may not qualify if:

  • a previous unusual response to any of the experimental anesthetics
  • severe cardiac dysrhythmias or ejection fraction below 30%
  • hemodynamic instability
  • previous surgical coronary artery repair
  • anemia, abnormal leukocytes or coagulopathy
  • severe hypertension
  • severe hepatic (albumin\<30g,ascites), renal (serum creatinine greater than 2.0 mg/dl) or pulmonary (preoperative pulmonary function tests moderate-severe) dysfunctions
  • concomitant surgical procedures and psychiatric disorders
  • Insulin-dependent diabetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

  • Jia L, Dong R, Zhang F, Wang W, Lu H, Luo Y, Xue Q, Yu B. Propofol Provides More Effective Protection for Circulating Lymphocytes Than Sevoflurane in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1172-9. doi: 10.1053/j.jvca.2015.01.008. Epub 2015 Feb 19.

    PMID: 26205644DERIVED

Related Links

MeSH Terms

Interventions

SevofluranePropofol

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title
Dr. Lijie Jia
Organization
Ruijin Hospital
litery0301@163.com
13916667704

Study Officials

  • Bu-Wei Yu, Ph.D., M.D.

    Department of Anesthesiology, Ruijin Hospital, Shanghai Jiao tong University School of Medicine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 28, 2011

Study Start

October 1, 2011

Primary Completion

February 1, 2012

Study Completion

October 1, 2014

Last Updated

May 22, 2015

Results First Posted

November 20, 2014

Record last verified: 2015-05

Locations

CN(1)