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

NCT ID: NCT02499445

Last Updated: 2015-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-11-30

Brief Summary

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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

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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).

Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Remifentanil and propofol

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

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

administering remifentanil for anesthesia maintenance

propofol

Intervention Type DRUG

administering propofol for anesthesia maintenance

remifentanil and sevoflurane 1

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

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

administering remifentanil for anesthesia maintenance

sevoflurane 1

Intervention Type DRUG

administering sevoflurane 1 for anesthesia maintenance

sevoflurane 2 and sufentanil

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

Group Type ACTIVE_COMPARATOR

sevoflurane 2

Intervention Type DRUG

administering sevoflurane 2 for anesthesia maintenance

sufentanil

Intervention Type DRUG

administering sufentanil for anesthesia maintenance

Interventions

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Remifentanil

administering remifentanil for anesthesia maintenance

Intervention Type DRUG

sevoflurane 1

administering sevoflurane 1 for anesthesia maintenance

Intervention Type DRUG

sevoflurane 2

administering sevoflurane 2 for anesthesia maintenance

Intervention Type DRUG

propofol

administering propofol for anesthesia maintenance

Intervention Type DRUG

sufentanil

administering sufentanil for anesthesia maintenance

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Konkuk University Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KUH1160004

Identifier Type: -

Identifier Source: org_study_id

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