MicroRNA Mediates Volatile Anesthetics Preconditioning Induced Artery Protection

NCT ID: NCT02678650

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31

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.

Conditions

Coronary Artery Bypass Graft Triple Vessel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

volatile anesthetics(isoflurane)

Intervention Type: DRUG

volatile anesthetics wash-in / wash-out operation

propofol intravenous anesthesia group

propofol infusion 3-5μg / kg / h

Group Type: PLACEBO_COMPARATOR

propofol intravenous anesthesia

Intervention Type: DRUG

propofol infusion 3-5μg / kg / h

Interventions

volatile anesthetics(isoflurane)

volatile anesthetics wash-in / wash-out operation

Intervention Type: DRUG

propofol intravenous anesthesia

propofol infusion 3-5μg / kg / h

Intervention Type: DRUG

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);
• kidney or liver transplant in medical history, liver cirrhosis (Child B or C);
• chronic respiratory disease (such as chronic obstructive pulmonary emphysema)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liang Zhang

OTHER

Sponsor Role: lead

Responsible Party

Liang Zhang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Ma, MD

Role: CONTACT

majun7689@163.com

010-64456329

Facility Contacts

Jun Ma, MD

Role: primary

majun7689@163.com

010-64456329

References

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.

Reference Type: DERIVED

PMID: 30683137 (View on PubMed)

Other Identifiers

2015017X

Identifier Type: -

Identifier Source: org_study_id