Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MicroRNA Mediates Volatile Anesthetics Preconditioning Induced Artery Protection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678650
Recruitment Status : Unknown
Verified February 2016 by Liang Zhang, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Liang Zhang, Beijing Anzhen Hospital

Tracking Information
First Submitted Date  ICMJE January 23, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date February 10, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
  • microRNA [ Time Frame: 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 [ Time Frame: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved) ]
  • phosphatidylinositol-3-kinase,alanine aminotransferase,endothelial nitric oxide synthase [ Time Frame: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
  • Change from microRNA [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MicroRNA Mediates Volatile Anesthetics Preconditioning Induced Artery Protection
Official Title  ICMJE Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University
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.
Detailed Description
  1. Sixty patients scheduled for off-pump coronary artery bypass surgery were randomly assigned to isoflurane wash-in/wash-out group(S-I group, n=30)or propofol intravenous anesthesia group(P group, n=30).
  2. Anesthesia and monitoring method All patients were monitored according to the American Society of Anesthesia guidelines and received standard general induction of anesthesia.
  3. SI group:10min after intubation,begin to isoflurane wash-in/wash-out operation:isoflurane 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 least 15 minutes during the last wash out time.
  4. P Group:propofol infusion 3-5μg/kg/h.
  5. When isoflurane inhaled anesthetic,propofol are stopped infusion.If during this interruption the BIS value increased to>50,0.5 mg/kg propofol was administered repeatedly in boluses until the BIS value have returned to<50.

6.1h after isoflurane preconditioning,specimens of internal mammary artery(surplus arterial tissue is obtained from the repair internal mammary artery)and ascending aorta(the stump after ascending aortic punch)will be saved, and before isoflurane preconditioning,1h,3h,5h after isoflurane preconditioning, central venous blood samples will also be drawn.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Bypass Graft Triple Vessel
Intervention  ICMJE
  • Drug: volatile anesthetics(isoflurane)
    volatile anesthetics wash-in / wash-out operation
  • Drug: propofol intravenous anesthesia
    propofol infusion 3-5μg / kg / h
Study Arms  ICMJE
  • Experimental: volatile anesthetics group
    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.
    Intervention: Drug: volatile anesthetics(isoflurane)
  • Placebo Comparator: propofol intravenous anesthesia group
    propofol infusion 3-5μg / kg / h
    Intervention: Drug: propofol intravenous anesthesia
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 5, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • inclusion in other randomised controlled studies in the previous 30 days; (10)any general anesthesia performed in the previous 30 days;
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02678650
Other Study ID Numbers  ICMJE 2015017X
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Liang Zhang, Beijing Anzhen Hospital
Study Sponsor  ICMJE Liang Zhang
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Anzhen Hospital
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP