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Completed

NCT Number: NCT02499445

Myocardial Injury in Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimens in OPCAB Surgery

In patients undergoing off-pump coronary artery bypass (OPCAB) surgery with different anesthesia regimens: remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP); remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml) (Group-SS), intergroup difference in the level of Troponin I (c-TnI) and creatinine kinase subtype-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), and one day after surgery (postoperative).

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

About this study

To determine the difference of myocardial injury upon using different anesthesia regimens: remifentanil-based regimen versus sevoflurane-sufentanil balanced regimen.

Patients undergoing off-pump coronary artery bypass (OPCAB) surgery are randomly allocated to get remifentanil (0.75 mcg/kg/min) and propofol (TCI effect-site concentration 0.8-1.5 mcg/ml) (Group -RP), remifentanil (0.75 mcg/kg/min) and sevoflurane (end-tidal 0.8 vol%) (Group-RS), or sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration0.35-0.75 ng/ml) (Group-SS).

Intergroup difference in the level of Troponin I (c-TnI) and creatine kinase-MB is determined before surgery (control), during vascular graft harvesting (harvesting), after completing graft construction (postgrafting), 1 day after surgery (postoperative).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient undergoing OPCAB surgery
  • patient signed written informed consent

Exclusion criteria

  • patient with Intra-aortic balloon pump
  • patient with renal replacement therapy
  • patient wants to withdraw the participation to the study

Treatment and study plan

Remifentanil

Drug

administering remifentanil for anesthesia maintenance

sevoflurane 1

Drug

administering sevoflurane 1 for anesthesia maintenance

sevoflurane 2

Drug

administering sevoflurane 2 for anesthesia maintenance

Propofol

Drug

administering propofol for anesthesia maintenance

Sufentanil

Drug

administering sufentanil for anesthesia maintenance

Primary outcomes

  1. troponin I

    Time frame: one day after surgery

    troponin I for myocardial injury

Secondary outcomes

  1. creatinin kinase-MB

    Time frame: one day after surgery

    creatinine kinase-MB

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Comparisons of Myocardial Injury After Using Different Anesthetics Regimens for Off-pump Coronary Artery Bypass Surgery: Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimen

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jul 16, 2015
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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