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Clinical Trials/NCT02407626
NCT02407626TerminatedNot Applicable

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

Triemli Hospital1 site in 1 country2 target enrollmentStarted: September 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
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

Experimental

Volatile anesthesia for elective cardiac surgery

Intervention: Sevoflurane (Drug)

Propofol

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christoph K Hofer

Prof. Dr. med.

Triemli Hospital

Study Sites (1)

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