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Clinical Trials/NCT02678650
NCT02678650
Unknown
Phase 4

Department of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University

Liang Zhang1 site in 1 country60 target enrollmentJanuary 2016

Overview

Phase
Phase 4
Intervention
volatile anesthetics(isoflurane)
Conditions
Coronary Artery Bypass Graft Triple Vessel
Sponsor
Liang Zhang
Enrollment
60
Locations
1
Primary Endpoint
microRNA
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Liang Zhang
Responsible Party
Sponsor Investigator
Principal Investigator

Liang Zhang

Principal Investigator

Beijing Anzhen Hospital

Eligibility 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);

Arms & Interventions

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: volatile anesthetics(isoflurane)

propofol intravenous anesthesia group

propofol infusion 3-5μg / kg / h

Intervention: propofol intravenous anesthesia

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • 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 Sites (1)

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