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

Not Applicable

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Drug: Remifentanil; Drug: sevoflurane 2; Drug: propofol; Drug: sevoflurane 1; Drug: sufentanil

• Registration Number: NCT02499445
• Lead Sponsor: Konkuk University Medical Center

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).

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Study First Submitted: 2015-03-05
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-16
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifentanil and propofol	Remifentanil	remifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml)
Remifentanil and propofol	propofol	remifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml)
remifentanil and sevoflurane 1	sevoflurane 1	remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%)
sevoflurane 2 and sufentanil	sevoflurane 2	sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml)
sevoflurane 2 and sufentanil	sufentanil	sevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml)
remifentanil and sevoflurane 1	Remifentanil	remifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%)

Primary Outcome Measures

Name	Time	Method
troponin I	one day after surgery	troponin I for myocardial injury

Secondary Outcome Measures

Name	Time	Method
creatinin kinase-MB	one day after surgery	creatinine kinase-MB

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of