OrthopedicsNCT02573558
Intraoperative Sedation and Postoperative Delirium
An observational study of Orthopedics, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Orthopedics
- What is being tested?
- Dexmedetomidine and Propofol
- How many people
- 855 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who underwent orthopedic surgery under regional anesthesia, and age of 65 years or greater
Who may be able to join
- Patients who underwent orthopedic surgery under regional anesthesia
- age of 65 years or greater
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
Official title: 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.
- Conditions
- Orthopedics
- Being tested
- Dexmedetomidine, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| DEX | patients who received dexmedetomidine during the operation Receives: Drug: Dexmedetomidine | |
| PPF | patients who received propofol during the operation Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
delirium
Measured: within 7 day postoperatively
Secondary outcomes (3)
Wound infection
Measured: within 7 day postoperatively
Pulmonary thromboembolism
Measured: within 7 day postoperatively
Hospital stay
Measured: through study completion, an average of 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicsStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 855 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573558
- Sponsor's protocol ID
- B-1510/318-104
- Status last verified
- Apr 2016
- First submitted
- 6 Oct 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Postoperative Delirium According to the Use of Dexmedetomidine or Propofol in Elderly Patients Undergoing Orthopedic Surgery: Retrospective Study
- ClinicalTrials.gov ID
- NCT02573558
- Acronym / sponsor ID
- B-1510/318-104
- Conditions
- Orthopedics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 855 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX | – | Drug: Dexmedetomidinepatients who received dexmedetomidine during the operation |
| PPF | – | Drug: Propofolpatients who received propofol during the operation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who underwent orthopedic surgery under regional anesthesia, and age of 65 years or greater
Key inclusion criteria (2 listed)
- Patients who underwent orthopedic surgery under regional anesthesia
- age of 65 years or greater
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine | Drug | DEX |
| Propofol | Drug | PPF |
Primary outcome
delirium
Time frame: within 7 day postoperatively
3 secondary outcomes
Wound infection
Time frame: within 7 day postoperatively
Pulmonary thromboembolism
Time frame: within 7 day postoperatively
Hospital stay
Time frame: through study completion, an average of 7days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedics, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delirium (time frame: within 7 day postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.