Postoperative Cognitive DysfunctionPhase 4NCT02931877
Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia
A Phase 4 study testing sevoflurane and propofol in people with Postoperative Cognitive Dysfunction, run by Xinqiao Hospital of Chongqing at 3 sites in China.
Trial summary
As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon, which affect patients' short-term and long-term outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac valvular surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- sevoflurane and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2016to Jun 2018
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who receive cardiac valvular surgery
- 18 to 65 years
- American society of anesthesiologists classification Ⅱto Ⅲ
- education level higher than elementary school
Who cannot join
- Patients are not expected to be alive for longer than 3 months.
- Mini-mental State Examination (MMSE) score ≤ 23.
- current use of sedatives or antidepressant
- history of dementia, psychiatric illness or any diseases of central nervous system.
- accompanying liver or kidney function deficiency
- history of some endocrine disease
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- alcoholism and drug dependence
- patients previously included in this study or currently included in the other clinical study
- patients who have second surgery during the study period
- difficult to follow up or patients with poor compliance
Trial locations and contacts
3 sites in 1 country.
China3 sites
Xinan Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400037
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400037
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Comparison of Postoperative Outcome and Cognitive Function After Sevoflurane and Propofol Anaesthesia for Cardiac Valvular Surgery With Cardiopulmonary Bypass
As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon, which affect patients' short-term and long-term outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most commonly used strategy for general anesthesia. At present, it was unknown that which one is better in providing cerebral protection effect for patients undergoing cardiac valvular surgery with CPB. The current study aimed to explore the possible difference.
Read the detailed description
The investigators hypothesize that the incidence of postoperative cognitive dysfunction (POCD) is not different in patients received intravenous anesthetics propofol or sevoflurane for their cardiac valvular surgery. Two groups of general anesthetics (propofol or sevoflurane) are used to explore the possible difference of the postoperative outcome and the incidence of POCD. After cardiac valvular surgery with CPB, patients' POCD tests at 7 days after the surgery, and postoperative delirium, etc., are evaluated by different questionnaires. Also the blood sample of these patients are collected for detection of some stress hormones.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- sevoflurane, propofol
- Keywords
- Sevoflurane, Propofol, Cardiac valvular surgery, Cardiopulmonary bypass, Postoperative cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevofluraneDrug
propofolDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery. Receives: Drug: sevoflurane |
| Propofol | Active comparator | Maintenance of anesthesia propofol during the cardiac valvular surgery. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with postoperative cognitive dysfunction (POCD)
POCD is a composite outcome measure
Measured: From 7 days after the surgery to the day of discharge from hospital
Secondary outcomes (1)
Postoperative delirium (POD)
POD is evaluated by a commonly used questionnaire
Measured: Up to 7 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Li, Xinqiao Hospital of Chongqing
- Investigators
- Hong Li, M.D., Principal investigator, Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931877
- Sponsor's protocol ID
- Li Hong-Group
- Status last verified
- Jul 2018
- First submitted
- 10 Oct 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Outcome and Cognitive Function After Sevoflurane and Propofol Anaesthesia for Cardiac Valvular Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02931877
- Acronym / sponsor ID
- Li Hong-Group
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Sevoflurane, Propofol, Cardiac valvular surgery, Cardiopulmonary bypass, Postoperative cognitive dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 13 Oct 2016 (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.
As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon, which affect patients' short-term and long-term outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most commonly used strategy for general anesthesia. At present, it was unknown that which one is better in providing cerebral protection effect for patients undergoing cardiac valvular surgery with CPB. The current study aimed to explore the possible difference.
Detailed description
The investigators hypothesize that the incidence of postoperative cognitive dysfunction (POCD) is not different in patients received intravenous anesthetics propofol or sevoflurane for their cardiac valvular surgery. Two groups of general anesthetics (propofol or sevoflurane) are used to explore the possible difference of the postoperative outcome and the incidence of POCD. After cardiac valvular surgery with CPB, patients' POCD tests at 7 days after the surgery, and postoperative delirium, etc., are evaluated by different questionnaires. Also the blood sample of these patients are collected for detection of some stress hormones.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: sevofluraneMaintenance of anesthesia with sevoflurane during the cardiac valvular surgery. |
| Propofol | Active comparator | Drug: propofolMaintenance of anesthesia propofol during the cardiac valvular surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients who receive cardiac valvular surgery
- 18 to 65 years
- American society of anesthesiologists classification Ⅱto Ⅲ
- education level higher than elementary school
Key exclusion criteria (10 listed)
- Patients are not expected to be alive for longer than 3 months.
- Mini-mental State Examination (MMSE) score ≤ 23.
- current use of sedatives or antidepressant
- history of dementia, psychiatric illness or any diseases of central nervous system.
- accompanying liver or kidney function deficiency
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 |
|---|---|---|
| sevoflurane | Drug | Sevoflurane |
| propofol | Drug | Propofol |
Primary outcome
Number of patients with postoperative cognitive dysfunction (POCD)
Time frame: From 7 days after the surgery to the day of discharge from hospital
POCD is a composite outcome measure
1 secondary outcome
Postoperative delirium (POD)
Time frame: Up to 7 days after the surgery
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 10 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Cognitive Dysfunction
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
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.
Hong Li, M.D. principal investigator
Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sevoflurane and propofol in people with Postoperative Cognitive Dysfunction, run by Xinqiao Hospital of Chongqing at 3 sites in China.
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 4 inclusion and 10 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients with postoperative cognitive dysfunction (POCD) (time frame: From 7 days after the surgery to the day of discharge from hospital). 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 10 Jul 2018.