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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02573558
Other study ID # B-1510/318-104
Secondary ID
Status Completed
Phase N/A
First received October 6, 2015
Last updated April 5, 2016
Start date October 2015
Est. completion date January 2016

Study information

Verified date April 2016
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority Institutional Review Board: Korea
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 855
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine

Propofol


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Myocardial ischemia within 7 day postoperatively No
Other Renal failure within 7 day postoperatively No
Other Hepatic failure within 7 day postoperatively No
Primary delirium within 7 day postoperatively No
Secondary Wound infection within 7 day postoperatively No
Secondary Pulmonary thromboembolism within 7 day postoperatively No
Secondary Hospital stay through study completion, an average of 7days No
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