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Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery (OPT)

T

Triemli Hospital

Status

Terminated

Conditions

Myocardial Ischemia

Treatments

Drug: Propofol
Drug: Sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT02407626
STZ-IFA-0115

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

Male

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diabetes
  • Elective cardiac surgery

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

Sevoflurane
Experimental group
Description:
Volatile anesthesia for elective cardiac surgery
Treatment:
Drug: Sevoflurane
Propofol
Active Comparator group
Description:
Total intravenous anesthesia for elective cardiac surgery
Treatment:
Drug: Propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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