Myocardial Injury in Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimens in OPCAB Surgery
Comparisons of Myocardial Injury After Using Different Anesthetics Regimens for Off-pump Coronary Artery Bypass Surgery: Remifentanil-based Versus Sevoflurane-sufentanil Balanced Regimen
1 other identifier
interventional
120
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedJuly 16, 2015
July 1, 2015
6.9 years
March 5, 2015
July 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
troponin I
troponin I for myocardial injury
one day after surgery
Secondary Outcomes (1)
creatinin kinase-MB
one day after surgery
Study Arms (3)
Remifentanil and propofol
ACTIVE COMPARATORremifentanil (0.75 mcg/kg/min) propofol (TCI effect-site concentration 0.8-1.5 mcg/ml)
remifentanil and sevoflurane 1
ACTIVE COMPARATORremifentanil (0.75 mcg/kg/min) sevoflurane (end-tidal 0.8 vol%)
sevoflurane 2 and sufentanil
ACTIVE COMPARATORsevoflurane (end-tidal 1.2-2.8 vol%)-sufentanil (TCI effect site concentration 0.35-0.75 ng/ml)
Interventions
administering remifentanil for anesthesia maintenance
administering sevoflurane 1 for anesthesia maintenance
Eligibility Criteria
You may qualify if:
- patient undergoing OPCAB surgery
- patient signed written informed consent
You may not qualify if:
- patient with Intra-aortic balloon pump
- patient with renal replacement therapy
- patient wants to withdraw the participation to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konkuk University Medical Center
Seoul, Seoul, 143-729, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
March 5, 2015
First Posted
July 16, 2015
Study Start
November 1, 2007
Primary Completion
October 1, 2014
Study Completion
November 1, 2014
Last Updated
July 16, 2015
Record last verified: 2015-07