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CompletedNCT02499445Updated Jul 16, 2015

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

An interventional study of Remifentanil and sevoflurane 1 in Ischemic Heart Disease, sponsored by Konkuk University Medical Center. Completed at 1 site in South Korea. Open to participants aged 19 Years to 72 Years. Per ClinicalTrials.gov, last updated 2015-07-16.

Sponsored by Konkuk University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
19 Years to 72 Years
Sex
All
01

Study summary

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).

Read the detailed description

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).

02

Conditions studied

  • Ischemic Heart Disease

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03

In context

Myocardial Ischemia

3,242 studies on the registry are indexed under Myocardial Ischemia; 390 are open to participants now.

This study's enrollment of 120 is close to the median of 120 across 1,901 interventional studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

Konkuk University Medical Center is the lead sponsor of 95 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patient undergoing OPCAB surgery
  • patient signed written informed consent

Exclusion criteria

Exclusion Criteria:

  • patient with Intra-aortic balloon pump
  • patient with renal replacement therapy
  • patient wants to withdraw the participation to the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Remifentanil and propofol

    remifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml)

    Drug: Remifentanil · Drug: propofol

  • Active comparator
    remifentanil and sevoflurane 1

    remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%)

    Drug: Remifentanil · Drug: sevoflurane 1

  • Active comparator
    sevoflurane 2 and sufentanil

    sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml)

    Drug: sevoflurane 2 · Drug: sufentanil

Interventions

  • administering remifentanil for anesthesia maintenance

  • Drugsevoflurane 1

    administering sevoflurane 1 for anesthesia maintenance

  • Drugsevoflurane 2

    administering sevoflurane 2 for anesthesia maintenance

  • administering propofol for anesthesia maintenance

  • administering sufentanil for anesthesia maintenance

06

What researchers measure

Primary outcomes

  1. troponin I

    troponin I for myocardial injury

    Time frame: one day after surgery

Secondary outcomes

  1. creatinin kinase-MB

    creatinine kinase-MB

    Time frame: one day after surgery

07

Study locations

1 site
  • Konkuk University Medical Center
    Seoul, Seoul 143-729, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02499445
Lead sponsor
Konkuk University Medical Center
Responsible party
Tae-Yop Kim, MD PhD (Professor of Anesthesiology, Konkuk University Medical Center) — Principal investigator
First posted
Jul 16, 2015
Start date
Nov 2007
Primary completion
Oct 2014
Completion
Nov 2014
Last update
Jul 16, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Remifentanil · Propofol · Sufentanil

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