Delirium,Phase 4LOGANDNCT01184638
Long-term Outcome of General Anesthesia on Dysgnosia
A Phase 4 study testing Sevoflurane and Propofol in people with Delirium, and Dementia,, run by Nanjing Medical University at 1 site in China.
Trial summary
Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Aug 2020
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with informed consents
- Without basal disorders of neurology and psychiatrics
Who cannot join
- With the history of cognitive disorders
- With chronic neurological disorders
- Cannot communicate with investigators
- Cannot stand general anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
YuZhu Peng, MD, 86 25 84460777 ext. 1508, pyz1131@hotmail.com
XiRong Guo, MD, 86 25 84460777 ext. 1508, xrguonjmueducn@yahoo.com.cn
About this study
Official title: Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia
Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Although controversial data reported from experimental studies in animals, the investigators still proposed that general anesthetics could impair the normally organized system of the central nervous system, which finally displayed a dysfunction of cognition after general anesthesia in a short- or long-term period. Therefore, different types of general anesthetics such as inhalational anesthetics and intravenous anesthetics, the investigators hypothesized, had a long-term influence on patients' cognitive ability.
- Conditions
- Delirium,, Dementia,, Amnestic,, Cognitive Disorders
- Being tested
- Sevoflurane, Propofol
- Keywords
- Cognitive Disorders, General anesthesia, Sevoflurane, Propofol, Memory
- Medical subject headings
- Delirium, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
1-8% sevoflurane for maintaining the whole period of general anesthesia
PropofolDrug
Also called Diprivan
1-4 mg/kg/h of propofol during the whole period of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia | No intervention | Patients received local anesthesia without any intervention of general anesthetics |
| Inhalational anesthesia | Active comparator | Patients received sevoflurane anesthesia during general anesthesia Receives: Drug: Sevoflurane |
| Intravenous anesthesia | Active comparator | Patients received intravenous anesthetic (Propofol) during general anesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Measured: The 10th year since postoperation
Secondary outcomes (6)
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Measured: One hour before operation
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Measured: Immediately after operation (0 day)
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Measured: One month after operation
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Measured: Six month after operation
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Measured: One year after operation
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Measured: Once a year from the 1st year after operation up to 9th year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium,Studies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Zhou Wang, Nanjing Medical University
- Investigators
- FuZhou Wang, PhD MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184638
- Sponsor's protocol ID
- NJMU-2010-07022
- Other IDs
- NJFY7M12
- Acronym
- LOGAND
- Status last verified
- Jan 2014
- First submitted
- 16 Aug 2010
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia
- ClinicalTrials.gov ID
- NCT01184638
- Acronym / sponsor ID
- LOGAND / NJMU-2010-07022
- Conditions
- Delirium,, Dementia,, Amnestic,, Cognitive Disorders
- Keywords
- Cognitive Disorders, General anesthesia, Sevoflurane, Propofol, Memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 19 Aug 2010 (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.
Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Although controversial data reported from experimental studies in animals, the investigators still proposed that general anesthetics could impair the normally organized system of the central nervous system, which finally displayed a dysfunction of cognition after general anesthesia in a short- or long-term period. Therefore, different types of general anesthetics such as inhalational anesthetics and intravenous anesthetics, the investigators hypothesized, had a long-term influence on patients' cognitive ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia | No intervention | –Patients received local anesthesia without any intervention of general anesthetics |
| Inhalational anesthesia | Active comparator | Drug: SevofluranePatients received sevoflurane anesthesia during general anesthesia |
| Intravenous anesthesia | Active comparator | Drug: PropofolPatients received intravenous anesthetic (Propofol) during general anesthesia |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with informed consents
- Without basal disorders of neurology and psychiatrics
Key exclusion criteria (4 listed)
- With the history of cognitive disorders
- With chronic neurological disorders
- Cannot communicate with investigators
- Cannot stand general anesthesia
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 |
|---|---|---|
| SevofluraneAlso: Sevorane1-8% sevoflurane for maintaining the whole period of general anesthesia | Drug | Inhalational anesthesia |
| PropofolAlso: Diprivan1-4 mg/kg/h of propofol during the whole period of general anesthesia | Drug | Intravenous anesthesia |
Primary outcome
Cognitive ability
Time frame: The 10th year since postoperation
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
6 secondary outcomes
Cognitive ability
Time frame: One hour before operation
Cognitive ability
Time frame: Immediately after operation (0 day)
Cognitive ability
Time frame: One month after operation
Cognitive ability
Time frame: Six month after operation
Cognitive ability
Time frame: One year after operation
Cognitive ability
Time frame: Once a year from the 1st year after operation up to 9th year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
FuZhou Wang, PhD MD study director
Nanjing Medical University
1 site 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 Delirium, and Dementia,, run by Nanjing 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 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: status not confirmed, as of the sponsor's last update on 14 Jan 2014. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FuZhou Wang, PhD MD (86 25 84460777 ext. 3301, zfwang50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive ability (time frame: The 10th year since postoperation). 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 14 Jan 2014.