NCT02678650

Brief Summary

It has been reported that volatile anesthetics preconditioning mediates protection of organ via microRNA. We want to study on the effects of isoflurane preconditioning on expression of microRNA and mRNA in the specimens of internal mammary artery and ascending aorta.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

January 23, 2016

Last Update Submit

February 5, 2016

Conditions

Coronary Artery Bypass Graft Triple Vessel

Keywords

Volatile AnestheticsMicroRNAOff-pump Coronary Artery Bypass SurgeryInternal Mammary ArteryAscending Aorta

Outcome Measures

Primary Outcomes (3)

  • microRNA

    1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)

  • NOS3 mRNA,mRNA levels of adhesion molecule selectin -E,vascular cell adhesion molecule -1,vascular endothelial growth factor -1,intercellular adhesion molecule,RhoA and ROK

    1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)

  • phosphatidylinositol-3-kinase,alanine aminotransferase,endothelial nitric oxide synthase

    1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved)

Secondary Outcomes (3)

  • Change from microRNA

    befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)

  • Change from ON content in serum,vascular cell adhesion molecule-1,intercellular adhesion molecules-1,adhesion molecule selectin-E,monocyte chemoattractant protein-1 and vascular endothelial growth factor-1

    befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)

  • Change from tumor necrosis factor-a,interleukin 1β,IL-6,IL-8 and IL-10

    befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn)

Study Arms (2)

volatile anesthetics group

EXPERIMENTAL

10min after intubation, begin to sevoflurane wash-in / wash-out operation: sevoflurane administration was interrupted for at least 10 min, by washout with a high fresh gas flow (10 l/min) to achieve a MAC value below 0.2. Following the interruption, sevoflurane was again washed in with a high fresh gas flow (6 l/min) to achieve 1 MAC end-tidal concentration as soon as possible, and repeated twice periods of 10 minutes. Discontinuation of the halogenated agent for at 15 minutes during the last wash out time.

Drug: volatile anesthetics(isoflurane)

propofol intravenous anesthesia group

PLACEBO COMPARATOR

propofol infusion 3-5μg / kg / h

Drug: propofol intravenous anesthesia

Interventions

volatile anesthetics(isoflurane)DRUG

volatile anesthetics wash-in / wash-out operation

volatile anesthetics group
propofol intravenous anesthesiaDRUG

propofol infusion 3-5μg / kg / h

propofol intravenous anesthesia group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>18 years
  • written informed consent;
  • scheduled procedures;
  • planned isolated OPCABG(multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed);
  • ejection fraction\> 50%;
  • NYHA class Ⅱ\~Ⅲ;
  • serum creatinine \<150μmol / l;
  • preoperative platelet content \> 100 × 109 / l;
  • preoperative hemoglobin\> 120 g / l

You may not qualify if:

  • pregnancy;
  • planned valve surgery or surgery on the aorta;
  • left main coronary artery stenosis\> 75%;
  • echocardiographic examination revealed moderate to severe mitral, tricuspid, or aortic regurgitation or stenosis;
  • unstable or ongoing angina;
  • recent (\< 1 month) or ongoing acute myocardial infarction;
  • use of sulfonylurea, theophylline or allopurinol;
  • previous unusual response to an anesthetic agent;
  • emergency operation (not scheduled);
  • kidney or liver transplant in medical history, liver cirrhosis (Child B or C);
  • chronic respiratory disease (such as chronic obstructive pulmonary emphysema)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100038, China

RECRUITING

Related Publications (1)

  • Zhang L, Wang CB, Li B, Lin DM, Ma J. RhoA/rho-kinase, nitric oxide and inflammatory response in LIMA during OPCABG with isoflurane preconditioning. J Cardiothorac Surg. 2019 Jan 25;14(1):22. doi: 10.1186/s13019-019-0835-9.

    PMID: 30683137DERIVED

Central Study Contacts

Jun Ma, MD

CONTACT

010-64456329majun7689@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2016

First Posted

February 10, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

CN(1)