Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimierung Der Kardioprotektion Durch Inhalative Anästhetika Eine Untersuchung Bei Patienten Mit Diabetes Mellitus während Off-pump Herzchirurgie

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes Elective cardiac surgery Exclusion Criteria: Emergency procedures Preop myocardial infarction Preop cardiac failure Preop renal replacement therapy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>Volatile anesthesia for elective cardiac surgery | Drug: Sevoflurane<br>* Volatile anesthesia is a clinical standard procedure<br>|
| Active Comparator: Propofol<br>Total intravenous anesthesia for elective cardiac surgery | Drug: Propofol<br>* Total intravenous anesthesia is a clinical standard procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker NT-proBNP | Difference between volatile anesthesia and total intravenous anesthesia | 1. after induction of anesthesia 2. after chest closure 3.-5. postoperative day 1, day 2, day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receptor Substrate phosphorylization (IRS-1)/PP2A | Difference between volatile anesthesia and total intravenous anesthesia | 1. beginning of cardiac surgery, 2. end of cardiac surgery | 
| Expression of TNF/IL1beta and microRNA (miR144, miR125b, miR208a) | Difference between volatile anesthesia and total intravenous anesthesia | 1. beginning of cardiac surgery, 2. end of cardiac surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemia, cardiac surgery, volatile anesthetic, total intravenous anesthesia