Intraoperative Sedation and Postoperative Delirium

Orthopedics Clinical Trial

Official title:

Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573558
• Other study ID #: B-1510/318-104
• 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

• Orthopedics

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