Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02407626

Acronym

OPT

Enrollment

Registered

2015-04-03

Start date

2015-09-30

Completion date

2018-03-07

Last updated

2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

ischemia, cardiac surgery, volatile anesthetic, total intravenous anesthesia

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.

Interventions

DRUGPropofol

Total intravenous anesthesia is a clinical standard procedure

DRUGSevoflurane

Volatile anesthesia is a clinical standard procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Diabetes * Elective cardiac surgery

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Receptor Substrate phosphorylization (IRS-1)/PP2A	1. beginning of cardiac surgery, 2. end of cardiac surgery	Difference between volatile anesthesia and total intravenous anesthesia
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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026