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

Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499445
• Other study ID #: KUH1160004
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: July 15, 2015
• Start date: November 2007
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 72 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Remifentanil
administering remifentanil for anesthesia maintenance
• sevoflurane 1
administering sevoflurane 1 for anesthesia maintenance
• sevoflurane 2
administering sevoflurane 2 for anesthesia maintenance
• propofol
administering propofol for anesthesia maintenance
• sufentanil
administering sufentanil for anesthesia maintenance

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	troponin I	troponin I for myocardial injury	one day after surgery	No
Secondary	creatinin kinase-MB	creatinine kinase-MB	one day after surgery	No