DeliriumNCT02374177
The Effects of Anaesthetic Agents on Postoperative Delirium
An observational study of Delirium, run by Konkuk University Medical Center.
Trial summary
The purpose of this study is to prove the correlation between the post-operative delirium (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump CABG. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delirium
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The medical records of the patients undergoing off-pump CABG in Konkuk University Medical Centre from Jan 2010 to Aug 2014 were retrospectively reviewed.
Who may be able to join
- Patients undergoing off-pump coronary artery bypass grafting
Who cannot join
- Other concurrent surgery
- Conversion from off-pump coronary artery bypass grafting to on-pump coronary artery bypass grafting
About this study
Official title: The Effects of Anaesthetic Agents on Postoperative Delirium in the Patients Undergoing Off-pump Coronary Artery Bypass Grafting Surgery
The purpose of this study is to prove the correlation between the post-operative delirium (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump CABG.
Read the detailed description
The medical records of the patients undergoing off-pump coronary artery bypass grafting (CABG) in Konkuk University Medical Centre from Jan 2010 to Aug 2014 were retrospectively reviewed.
- Conditions
- Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Patient anesthetized using propofol | |
| Sevoflurane group | Patients anesthetized using sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Measured: up to postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- Time perspective
- Retrospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seong-Hyop Kim, Professor, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374177
- Sponsor's protocol ID
- KUH1160073
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2015
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Koster S, Hensens AG, van der Palen J. The long-term cognitive and functional outcomes of postoperative delirium after cardiac surgery. Ann Thorac Surg. 2009 May;87(5):1469-74. doi: 10.1016/j.athoracsur.2009.02.080.
PubMed 19379886
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anaesthetic Agents on Postoperative Delirium in the Patients Undergoing Off-pump Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT02374177
- Acronym / sponsor ID
- KUH1160073
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Feb 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.
The purpose of this study is to prove the correlation between the post-operative delirium (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump CABG.
Detailed description
The medical records of the patients undergoing off-pump coronary artery bypass grafting (CABG) in Konkuk University Medical Centre from Jan 2010 to Aug 2014 were retrospectively reviewed.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | – | –Patient anesthetized using propofol |
| Sevoflurane group | – | –Patients anesthetized using sevoflurane |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The medical records of the patients undergoing off-pump CABG in Konkuk University Medical Centre from Jan 2010 to Aug 2014 were retrospectively reviewed.
Key inclusion criteria (1 listed)
- Patients undergoing off-pump coronary artery bypass grafting
Key exclusion criteria (2 listed)
- Other concurrent surgery
- Conversion from off-pump coronary artery bypass grafting to on-pump coronary artery bypass grafting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative delirium
Time frame: up to postoperative 7 days
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 27 Feb 2015.
- Background: PubMed 19379886Koster S, Hensens AG, van der Palen J. The long-term cognitive and functional outcomes of postoperative delirium after cardiac surgery. Ann Thorac Surg. 2009 May;87(5):1469-74. doi: 10.1016/j.athoracsur.2009.02.080.
Related trials for Delirium
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
Seong-Hyop Kim, Professor principal investigator
Konkuk University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Konkuk University Medical Center.
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 1 inclusion and 2 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 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of postoperative delirium (time frame: up to postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374177, which also lists 1 linked publication.
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 27 Feb 2015.