Assessment of the possible protective effect of anesthetics on the heart in patients undergoing cardiac surgery.

MicroRNAs expression analysis in patients undergoing cardiac surgery treated with halogenated anesthetics. Identification of microRNAs related to the cardioprotective effect

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003413-10-ES

Enrollment

Unknown

Registered

2016-09-09

Start date

2016-12-20

Completion date

Unknown

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac surgery

Interventions

Trade Name: SEVORANE Product Name: SEVOFLURANE Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: SEVOFLURANE CAS Number: 28523-86-6 Other descriptive name: SEVOFLURANE Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 year old. 2. Elective off-pump coronary artery bypass surgery. 3. EUROSCORE (European level of risk, useful in the perioperative period of patients undergoing cardiac surgery, validated at medical and scientific level) under 8 (cardiological moderate risk in the perioperative). 4. Degree of anesthetic risk according to the American Society of Anesthesiologists (ASA) less than 4 (moderate-risk patient high anesthetic). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 128 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. History of adverse reaction to anesthetic drugs. 2. Severe illness of any organ (lung, liver, kidney), diagnosed preoperatively. 3. Combined surgery (eg valve repair or carotid surgery). 4. Patients in situations of hemodynamic instability. 5. Heart failure or need for use of inotropes or vasoactive pre-intervention. 6. Treatment with oral antidiabetic drugs at least 48 hours before. 7. Pre-intervention treatment with eufilina/theophylline. 8. Inability to grant informed consent. 9. Pregnancy or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Analyze variation of microRNAs in human serum of patients at high risk of ischemic heart disease undergoing coronary artery bypass surgery with pre and postoperative administration of sevoflurane (cardioprotective effect) compared with those who were he administered propofol (no cardioprotective effect described). 2. Analyze variation in cardioprotective microRNAs expression levels using a quantitative technique, in human serum of patients at high risk of ischemic heart disease undergoing cardiac pre-postconditionings protocol with sevoflurane anesthesia. 3. Analyze the initial and final levels of various serum microRNA in human patients at high risk of ischemic heart disease, and analyze whether there is a correlation between this variation and the morbidity and mortality of patients.;Secondary Objective: Not applicable;Primary end point(s): 1. Damage and myocardial injury (NT-proBNP levels, troponinaI, CK and CKMMB). 2. Cardiac Output Index;Timepoint(s) of evaluation of this end point: Discharge Report of intensive care unit	—

Measure

Time frame

Main Objective: 1. Analyze variation of microRNAs in human serum of patients at high risk of ischemic heart disease undergoing coronary artery bypass surgery with pre and postoperative administration of sevoflurane (cardioprotective effect) compared with those who were he administered propofol (no cardioprotective effect described). 2. Analyze variation in cardioprotective microRNAs expression levels using a quantitative technique, in human serum of patients at high risk of ischemic heart disease undergoing cardiac pre-postconditionings protocol with sevoflurane anesthesia. 3. Analyze the initial and final levels of various serum microRNA in human patients at high risk of ischemic heart disease, and analyze whether there is a correlation between this variation and the morbidity and mortality of patients.;Secondary Objective: Not applicable;Primary end point(s): 1. Damage and myocardial injury (NT-proBNP levels, troponinaI, CK and CKMMB). 2. Cardiac Output Index;Timepoint(s) of evaluation of this end point: Discharge Report of intensive care unit

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Arrhythmias. 2. Number of days in Intensive Care Unit 3. Total number of days hospitalised. 4. MicroRNA quantitative values. 5. Mortality rate.;Timepoint(s) of evaluation of this end point: Hospital Discharge Report (postsurgery)	—

Countries

Spain

Contacts

Public ContactClinical Trials Unit

FIMABIS

gloria.luque@fimabis.org34951291977

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026