Cognitive Impairment, MildMCINCT03165396
Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With MCI
A study testing Propofol and Sevoflurane in people with Cognitive Impairment, Mild, run by The Third Central Clinical College of Tianjin Medical University at 1 site in China.
Trial summary
According to the inclusion and exclusion criteria, elderly patients undergoing elective orthopedic surgery were randomly divided into four groups. The different combinations of propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients become wide-awake, and 3 days, 7 days, and 3… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Mild
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2016to 1 Nov 2018
- Phase
- Interventional
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective orthopaedic surgery
- American Society of Anesthesiologists physical status: II
Who cannot join
- Neurological diseases that may affect cognitive function (e.g., subdural hematoma)
- Hypothyroidism
- Alcoholic dementia
Trial locations and contacts
1 site in 1 country.
Yimeng Chen contact
China1 site, 1 recruiting
- Recruiting
Third Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 022
Haiyun Wang, why819@126.com
About this study
Official title: The Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With Mild Cognitive Impairment
According to the inclusion and exclusion criteria, elderly patients undergoing elective orthopedic surgery were randomly divided into four groups. The different combinations of propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive function was evaluated using a professional cognitive scale and other indicators. Finally, statistical analysis.
- Conditions
- Cognitive Impairment, Mild
- Being tested
- Propofol, Sevoflurane
- Keywords
- mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol is the most common clinical anesthetics.
SevofluraneDrug
Sevoflurane is the most common clinical anesthetics.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | administrated Target Controlled Infusion （TCI）of propofol （Cp 2.0~2.5μg/ml ）for maintaining Receives: Drug: Propofol |
| 1.2 μg/ml Propofol | Experimental | administrated Target Controlled Infusion （TCI）of propofol （Cp 1.2 μg/ml ）combined with appropriate sevoflurane for maintaining Receives: Drug: Propofol; Drug: Sevoflurane |
| 0.6 μg/ml Propofol | Experimental | administrated Target Controlled Infusion （TCI）of propofol （Cp 0.6 μg/ml ）combined with appropriate sevoflurane for maintaining Receives: Drug: Propofol; Drug: Sevoflurane |
| Sevoflurane | Experimental | administrated 1.3 minimum alveolar concentration（MAC ） sevoflurane for maintaining Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ）
Measurement by ELISA kit
Measured: Change from Baseline Apolipoprotein J at 7 days
Secondary outcomes (3)
Evidence of clinically cognitive function decline ：Soluble CD14（sCD14）
Estimating by ELISA kit
Measured: Change from Baseline Soluble CD14 at 7 days
Mini mental Examination(MMSE)
A questionnaires is used to assess the cognitive function of patients in clinical.Total range was 0~30，≦27 were considered as cognitive function decline
Measured: preoperative 24 hours ， 7 days post surgery
Montreal Cognitive Assessment（MoCA)
A questionnaires is used to assess the cognitive function of patients in clinical.Total range was 0~30，≦27 were considered as cognitive function decline.
Measured: preoperative 24 hours ，7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start10 Nov 2016
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment, MildStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Central Clinical College of Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165396
- Sponsor's protocol ID
- szxlcyj-chen
- Acronym
- MCI
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03165396
- Acronym / sponsor ID
- MCI / szxlcyj-chen
- Conditions
- Cognitive Impairment, Mild
- Keywords
- mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Third Central Clinical College of Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 24 May 2017 (actual)
- 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.
According to the inclusion and exclusion criteria, elderly patients undergoing elective orthopedic surgery were randomly divided into four groups. The different combinations of propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive function was evaluated using a professional cognitive scale and other indicators. Finally, statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Propofoladministrated Target Controlled Infusion （TCI）of propofol （Cp 2.0~2.5μg/ml ）for maintaining |
| 1.2 μg/ml Propofol | Experimental | Drug: Propofol, Drug: Sevofluraneadministrated Target Controlled Infusion （TCI）of propofol （Cp 1.2 μg/ml ）combined with appropriate sevoflurane for maintaining |
| 0.6 μg/ml Propofol | Experimental | Drug: Propofol, Drug: Sevofluraneadministrated Target Controlled Infusion （TCI）of propofol （Cp 0.6 μg/ml ）combined with appropriate sevoflurane for maintaining |
| Sevoflurane | Experimental | Drug: Sevofluraneadministrated 1.3 minimum alveolar concentration（MAC ） sevoflurane for maintaining |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective orthopaedic surgery
- American Society of Anesthesiologists physical status: II
Key exclusion criteria (3 listed)
- Neurological diseases that may affect cognitive function (e.g., subdural hematoma)
- Hypothyroidism
- Alcoholic dementia
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 |
|---|---|---|
| PropofolPropofol is the most common clinical anesthetics. | Drug | 0.6 μg/ml Propofol, 1.2 μg/ml Propofol, Propofol |
| SevofluraneSevoflurane is the most common clinical anesthetics. | Drug | 0.6 μg/ml Propofol, 1.2 μg/ml Propofol, Sevoflurane |
Primary outcome
Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ）
Time frame: Change from Baseline Apolipoprotein J at 7 days
Measurement by ELISA kit
3 secondary outcomes
Evidence of clinically cognitive function decline ：Soluble CD14（sCD14）
Time frame: Change from Baseline Soluble CD14 at 7 days
Mini mental Examination(MMSE)
Time frame: preoperative 24 hours ， 7 days post surgery
Montreal Cognitive Assessment（MoCA)
Time frame: preoperative 24 hours ，7 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: Yes
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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.
Yimeng Chen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Cognitive Impairment, Mild, run by The Third Central Clinical College of Tianjin Medical University at 1 site 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 May 2018. 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 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiyun Wang (86-13752211206, why@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ） (time frame: Change from Baseline Apolipoprotein J at 7 days). 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 25 May 2018.