Intraoperative Sedation and Postoperative Delirium

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02573558
• Collaborator: (none)
• Enrollment: 855
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 282.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedics	Drug: Dexmedetomidine; Drug: Propofol

Study Design

• Study Type: Observational
• Actual Enrollment: 855 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
DEX patients who received dexmedetomidine during the operation	Drug: Dexmedetomidine
PPF patients who received propofol during the operation	Drug: Propofol

Outcome Measures

Primary Outcome Measures

1. delirium [within 7 day postoperatively]

Secondary Outcome Measures

1. Wound infection [within 7 day postoperatively]

2. Pulmonary thromboembolism [within 7 day postoperatively]

3. Hospital stay [through study completion, an average of 7days]

Other Outcome Measures

1. Myocardial ischemia [within 7 day postoperatively]

2. Renal failure [within 7 day postoperatively]

3. Hepatic failure [within 7 day postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyo-Seok Na, Associate Professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT02573558
• Other Study ID Numbers: B-1510/318-104
• First Posted: Oct 12, 2015
• Last Update Posted: Apr 6, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Delirium; Dexmedetomidine; Propofol

Study Results

No Results Posted as of Apr 6, 2016