Optimierung Der Kardioprotektion Durch Inhalative Anästhetika Eine Untersuchung Bei Patienten Mit Diabetes Mellitus während Off-pump Herzchirurgie
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Triemli Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Biomarker NT-proBNP
Study Overview
Brief Summary
This study evaluates the myocardial protection against perioperative ischemia comparing two standard anesthetic regimes in diabetic patients undergoing elective cardiac surgery. Half of the patients will receive volatile anesthesia while the other half will receive total intravenous anesthesia. Primary and secondary outcome parameters will be assessed after induction of anesthesia, at the end of the procedure and postoperative day 1 to 3.
Detailed Description
Volatile anaesthetics such as Sevoflurane have shown to have a protective effect regarding myocardial ischemia in the perioperative setting - the so-called "preconditioning". However the observed response of preconditioning in clinical trials is not consistent.
An increased perioperative insulin resistance especially in diabetic patients resulting in an increased postoperative morbidity and mortality may be responsible for these findings.
In an animal model, the use of propofol that is being routinely applied for general anesthesia was associated with a change of the insulin receptor substrate via phosphorylation and thus a change of insulin resistance.
Avoiding a total intravenous anesthesia and applying a volatile anesthesia may result in an increased cardioprotective effect by a reduction of the perioperative insulin resistance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective cardiac surgery
Exclusion Criteria
- •Emergency procedures
- •Preop myocardial infarction
- •Preop cardiac failure
- •Preop renal replacement therapy
Arms & Interventions
Sevoflurane
Volatile anesthesia for elective cardiac surgery
Intervention: Sevoflurane (Drug)
Propofol
Total intravenous anesthesia for elective cardiac surgery
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Biomarker NT-proBNP
Time Frame: 1. after induction of anesthesia 2. after chest closure 3.-5. postoperative day 1, day 2, day 3
Difference between volatile anesthesia and total intravenous anesthesia
Secondary Outcomes
- Expression of TNF/IL1beta and microRNA (miR144, miR125b, miR208a)(1. beginning of cardiac surgery, 2. end of cardiac surgery)
- Receptor Substrate phosphorylization (IRS-1)/PP2A(1. beginning of cardiac surgery, 2. end of cardiac surgery)
Investigators
Christoph K Hofer
Prof. Dr. med.
Triemli Hospital