The Effects of Anaesthetic Agents on Postoperative Delirium | NCT02374177

Studies
The Effects of Anaesthetic Agents on Postoperative Delirium

NCT02374177

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Feb 27, 2015Estimated

Enrollment

292Actual

Phase

Not provided

Conditions

Delirium

Interventions

Not provided

Countries

Not provided

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

Feb 2015

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

Nov 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Feb 4, 2015

First Submission Date that Met QC Criteria

Feb 23, 2015

First Posted Date

Feb 27, 2015Estimated

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

Feb 23, 2015

Last Update Posted Date

Feb 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to prove the correlation between the post-operative delirium (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump CABG.

Detailed Description

The medical records of the patients undergoing off-pump coronary artery bypass grafting (CABG) in Konkuk University Medical Centre from Jan 2010 to Aug 2014 were retrospectively reviewed.

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

292Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propofol group		Patient anesthetized using propofol
Sevoflurane group		Patients anesthetized using sevoflurane

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative delirium		up to postoperative 7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing off-pump coronary artery bypass grafting

Exclusion Criteria:

Other concurrent surgery
Conversion from off-pump coronary artery bypass grafting to on-pump coronary artery bypass grafting

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The medical records of the patients undergoing off-pump CABG in Konkuk University Medical Centre from Jan 2010 to Aug 2014 were retrospectively reviewed.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seong-Hyop Kim, Professor	Konkuk University Medical Center	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19379886	Background	Koster S, Hensens AG, van der Palen J. The long-term cognitive and functional outcomes of postoperative delirium after cardiac surgery. Ann Thorac Surg. 2009 May;87(5):1469-74. doi: 10.1016/j.athoracsur.2009.02.080.

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases