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

Primary Purpose

Ischemic Heart Disease

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Remifentanil

sevoflurane 1

sevoflurane 2

propofol

sufentanil

About this trial

This is an interventional treatment trial for Ischemic Heart Disease

Eligibility Criteria

19 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Konkuk University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Remifentanil and propofol

remifentanil and sevoflurane 1

sevoflurane 2 and sufentanil

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

troponin I

troponin I for myocardial injury

Secondary Outcome Measures

creatinin kinase-MB

creatinine kinase-MB

Full Information

NCT ID

NCT02499445

First Posted

March 5, 2015

Last Updated

July 15, 2015

Sponsor

Konkuk University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02499445

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Konkuk University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remifentanil and propofol

Arm Type

Active Comparator

Arm Description

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

Arm Title

remifentanil and sevoflurane 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

sevoflurane 2 and sufentanil

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Remifentanil

Intervention Description

administering remifentanil for anesthesia maintenance

Intervention Type

Drug

Intervention Name(s)

sevoflurane 1

Intervention Description

administering sevoflurane 1 for anesthesia maintenance

Intervention Type

Drug

Intervention Name(s)

sevoflurane 2

Intervention Description

administering sevoflurane 2 for anesthesia maintenance

Intervention Type

Drug

Intervention Name(s)

propofol

Intervention Description

administering propofol for anesthesia maintenance

Intervention Type

Drug

Intervention Name(s)

sufentanil

Intervention Description

administering sufentanil for anesthesia maintenance

Primary Outcome Measure Information:

Title

troponin I

Description

troponin I for myocardial injury

Time Frame

one day after surgery

Secondary Outcome Measure Information:

Title

creatinin kinase-MB

Description

creatinine kinase-MB

Time Frame

one day after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

143-729

Country

Korea, Republic of

12. IPD Sharing Statement

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

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