Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery

Not Applicable

Terminated

• Conditions: Myocardial Ischemia
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT02407626
• Lead Sponsor: Triemli Hospital

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 Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-04-03
• Study Start: 2015-09
• Status Verified: 2018-03
• Primary Completion: 2018-03-07
• Study Completion: 2018-03-07
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

Inclusion Criteria

• Diabetes
• Elective cardiac surgery

Exclusion Criteria

• Emergency procedures
• Preop myocardial infarction
• Preop cardiac failure
• Preop renal replacement therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	Sevoflurane	Volatile anesthesia for elective cardiac surgery
Propofol	Propofol	Total intravenous anesthesia for elective cardiac surgery

Primary Outcome Measures

Name	Time	Method
Biomarker NT-proBNP	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 Outcome Measures

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

Trial Locations

Locations (1)

Triemli City Hospital; 🇨🇭 Zurich, Switzerland