NCT02573558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
855

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

October 6, 2015

Last Update Submit

April 5, 2016

Conditions

Orthopedics

Outcome Measures

Primary Outcomes (1)

  • delirium

    within 7 day postoperatively

Secondary Outcomes (3)

  • Wound infection

    within 7 day postoperatively

  • Pulmonary thromboembolism

    within 7 day postoperatively

  • Hospital stay

    through study completion, an average of 7days

Other Outcomes (3)

  • Myocardial ischemia

    within 7 day postoperatively

  • Renal failure

    within 7 day postoperatively

  • Hepatic failure

    within 7 day postoperatively

Study Arms (2)

DEX

patients who received dexmedetomidine during the operation

Drug: Dexmedetomidine

PPF

patients who received propofol during the operation

Drug: Propofol

Interventions

DexmedetomidineDRUG
DEX
PropofolDRUG
PPF

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

DexmedetomidinePropofol

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 12, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

KR(1)