Volatile Versus Propofol Anesthesia in OPCAB | NCT02222142

Studies
Volatile Versus Propofol Anesthesia in OPCAB

NCT02222142

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Aug 21, 2014Estimated

Enrollment

1,080Actual

Phase

Not provided

Conditions

Off Pump Coronary Artery Bypass Graft

Interventions

Isoflurane

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 17, 2014

First Submission Date that Met QC Criteria

Aug 20, 2014

First Posted Date

Aug 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2014

Last Update Posted Date

Aug 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to intermittent regional ischemic episode. The investigators retrospectively evaluated the cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB.

Detailed Description

Several experimental and clinical researches have suggested that volatile anesthetics may reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective effect. Off-pump coronary artery bypass graft (OPCAB) surgery still requires cardioprotective strategies due to coronary hypoperfusion during anastomosis. The aim of this study was to evaluate the possible cardioprotective effect and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB using propensity matching.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,080Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Isoflurane group		Isoflurane inhalational anesthesia during OPCAB	Drug: Isoflurane
Propofol group		Total intravenous anesthesia with propofol during OPCAB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isoflurane	Drug	Comparison between isoflurane and propofol, Retrospective study	Isoflurane group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CK-MB, CRP	Comparison of CK-MB and CRP values between propofol and isoflurane groups on postoperative day, POD1 and POD 2	Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2

Secondary Outcomes

Measure	Description	Time Frame
Clinical adverse outcomes	clinical adverse outcomes until postoperative 1 year	until 1 year after OPCAB

Other Outcomes

Measure	Description	Time Frame
Cardioprotection and clinical adverse outcomes in diabetic patients	primary and secondary outcome analysis in diabetic patients	POD, POD 1, POD 2, one month, one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

OPCAB

Exclusion Criteria:

On pump conversion

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients underwent OPCAB from January, 2010 to December, 2012

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung medical center		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007530	Isoflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided