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MicroRNA Mediates Volatile Anesthetics Preconditioning Induced Artery Protection

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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Graft Triple Vessel Drug: volatile anesthetics(isoflurane) Drug: propofol intravenous anesthesia Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
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.
Drug: volatile anesthetics(isoflurane)
volatile anesthetics wash-in / wash-out operation

Placebo Comparator: propofol intravenous anesthesia group
propofol infusion 3-5μg / kg / h
Drug: propofol intravenous anesthesia
propofol infusion 3-5μg / kg / h




Primary Outcome Measures :
  1. microRNA [ Time Frame: 1h after isoflurane treatment(specimens of internal mammary artery and ascending aorta stump are saved) ]
  2. 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) ]
  3. 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) ]

Secondary Outcome Measures :
  1. Change from microRNA [ Time Frame: befor isoflurane treatment,1h,3h,5h after isoflurane treatment(central venous blood samples are drawn) ]
  2. 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) ]
  3. 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) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678650


Contacts
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Contact: Jun Ma, MD 010-64456329 majun7689@163.com

Locations
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China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100038
Contact: Jun Ma, MD    010-64456329    majun7689@163.com   
Sponsors and Collaborators
Liang Zhang
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liang Zhang, Principal Investigator, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02678650    
Other Study ID Numbers: 2015017X
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Liang Zhang, Beijing Anzhen Hospital:
Volatile Anesthetics
MicroRNA
Off-pump Coronary Artery Bypass Surgery
Internal Mammary Artery
Ascending Aorta
Additional relevant MeSH terms:
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Anesthetics
Propofol
Isoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation