Intraoperative Sedation and Postoperative Delirium | NCT02573558

Studies
Intraoperative Sedation and Postoperative Delirium

NCT02573558

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Apr 6, 2016Estimated

Enrollment

855Actual

Phase

Not provided

Conditions

Orthopedics

Interventions

Dexmedetomidine
Propofol

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

Apr 2016

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

Oct 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Oct 6, 2015

First Submission Date that Met QC Criteria

Oct 7, 2015

First Posted Date

Oct 12, 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

Apr 5, 2016

Last Update Posted Date

Apr 6, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyo-Seok Na, Associate Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

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

Delirium are common after orthopedic surgery in the elderly and are directly associated with loss of independence, reduction in the quality of life and increased mortality. The cause of postoperative delirium still remains unclear and may be multifactorial. The aim of this retrospective study is to examine prevalence of postoperative delirium according to the use of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under regional anesthesia.

Detailed Description

Not provided

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

855Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DEX		patients who received dexmedetomidine during the operation	Drug: Dexmedetomidine
PPF		patients who received propofol during the operation	Drug: Propofol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug		DEX
Propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
delirium		within 7 day postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Wound infection		within 7 day postoperatively
Pulmonary thromboembolism		within 7 day postoperatively
Hospital stay

Other Outcomes

Measure	Description	Time Frame
Myocardial ischemia		within 7 day postoperatively
Renal failure		within 7 day postoperatively
Hepatic failure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent orthopedic surgery under regional anesthesia
age of 65 years or greater

Exclusion Criteria:

General anesthesia
age < 65 years
central nervous system disease, including dementia and Parkinson's disease
Patients who were not received sedation with propofol or dexmedetomidine during the operation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patients who underwent orthopedic surgery under regional anesthesia, and age of 65 years or greater

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do		South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D015742	Propofol

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided