- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02573558
Intraoperative Sedation and Postoperative Delirium
April 5, 2016 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital
Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
855
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi
-
Seongnam, Gyeonggi, Korea, Republic of
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who underwent orthopedic surgery under regional anesthesia, and age of 65 years or greater
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DEX
patients who received dexmedetomidine during the operation
|
|
PPF
patients who received propofol during the operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
delirium
Time Frame: within 7 day postoperatively
|
within 7 day postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound infection
Time Frame: within 7 day postoperatively
|
within 7 day postoperatively
|
Pulmonary thromboembolism
Time Frame: within 7 day postoperatively
|
within 7 day postoperatively
|
Hospital stay
Time Frame: through study completion, an average of 7days
|
through study completion, an average of 7days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Myocardial ischemia
Time Frame: within 7 day postoperatively
|
within 7 day postoperatively
|
Renal failure
Time Frame: within 7 day postoperatively
|
within 7 day postoperatively
|
Hepatic failure
Time Frame: within 7 day postoperatively
|
within 7 day postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
October 6, 2015
First Submitted That Met QC Criteria
October 7, 2015
First Posted (Estimate)
October 12, 2015
Study Record Updates
Last Update Posted (Estimate)
April 6, 2016
Last Update Submitted That Met QC Criteria
April 5, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Propofol
- Dexmedetomidine
Other Study ID Numbers
- B-1510/318-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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