Evaluation of myocardial and clinical beneficial effect of sevoflurane in intraoperative and postoperative myocardial revascularization surgery, compared with propofol

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2013
INTERVENTION: 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 unit: ml millilitre(s) Concentration type: equal Concentration number: 1‐ Trade Name: Propofol Lipomed Fresenius Product Name: Propofol Pharmaceutical Form: Emulsion for injection/infusion INN or Proposed INN: Propofol Other descriptive name: PROPOFOL Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 1.2 ‐2.5 CONDITION: Assessment of the beneficial effects of sevoflurane during the intraoperative and immediate postoperative myocardial revascularization surgery. Assessment will be through biochemical markers of myocardial injury and dysfunction Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: To assess the effects of sevoflurane on intra‐and postoperative patients undergoing myocardial revascularization surgery compared to propofol in terms of harm reduction and myocardial injury Primary end point(s): Damage and myocardial injury (NT‐proBNP levels, troponinaI, CK and CKMMB) Secondary Objective: Knowledge of the mechanisms by which myocardial protection occurs in both intraoperatively and postoperatively, determining which of the different effector pathways of preconditioning and postconditioning; ; Determine length of stay in the intensive care unit of each of the groups to determine if the potentiation of the effect through the postoperative administration, reduces per se the stay in the intensive care unit; ; Identify differences in rhythm disorder episodes (tachyarrhythmias), thanks mainly to the effects of postconditioning, and the biochemical basis of this beneficial effect Timepoint(s) of evaluation of this end point: Discharge Report of intensive care unit SECONDARY OUTCOME: Secondary end point(s): Cardiac rhythm disorder episodes ; Days of stay in the intensive care unit Timepoint(s) of evaluation of this end point: Discharge Report of intensive care unit INCLUSION CRITERIA: 1. Elective off‐pump CABG. 2.EUROSCORE (European level of risk, useful in the perioperative period of cardiac surgery patients, validated medical and scientific level) under 8 (moderate risk in the perioperative cardiac). 3. Anesthetic risk level according to the American Society of Anesthesia (ASA) of less than 4 (moderate anesthetic risk patient‐high). 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: e06684b3642fc14704337b868ae1336ab4e15d6d
First added on: Aug 22, 2024