Necrosis of Femoral HeadKPPOCDNCT02220400
Ketamine Prevent POCD
A study testing Ketamine in people with Necrosis of Femoral Head and Knee Osteoarthritis, run by RenJi Hospital at 3 sites in China.
Trial summary
Previous study demonstrated that neuroinflammation induced by surgery is the main cause of the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved to be an anti-inflammation agent. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Necrosis of Femoral Head, Knee Osteoarthritis
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 484 participants
- Where
- 3 sitesChina
- Study dates
- Sep 2014to Sep 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elder than 60
- Easily communicated with Chinese
- Selected to kneel or hip replacement
- Agree to take part into this clinical trail
Who cannot join
- Existing cerebral disease， or have a history of neurological and psychiatric disease including AD, stroke and psychosis
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- Several audition or vision disorder
- Preoperative systolic Blood pressure over 190mmHg or diastolic pressure >100mmHg
- Existing a history of hyperthyroidism
- Patient with glaucoma
- Unwillingness to comply with the protocol or procedures
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Xiaoqing Zhang, M.S., xq_820175@163.com
Xiaoqing Zhang, M.S.
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
Diansan Su, Dr., 0086-21-68383702, diansansu@yahoo.com
Diansan Su, Dr.
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality
Lizhi Li, M.S., Fmlilizhi@sina.com.cn
Lizhi Li, M.S.
About this study
Official title: Low Dose Ketamine Prevent the Postoperative Cognitive Dysfunction in Aged Patients Underwent Orthopaedic Surgery，a Randomized Control Double Blinded Multicenter Clinical Trail
Previous study demonstrated that neuroinflammation induced by surgery is the main cause of the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved to be an anti-inflammation agent. In present study investigators hypothesized that low dose ketamine would prevent the cognition decline after orthopedic surgery in aged patients.
- Conditions
- Necrosis of Femoral Head, Knee Osteoarthritis
- Being tested
- Ketamine
- Keywords
- Postoperative cognitive dysfunction, Ketamine, Surgery
- Medical subject headings
- Osteoarthritis, Knee, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Ketamine infusion group Receives: Drug: Ketamine |
| Placebo | Placebo comparator | Normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term cognitive changes after surgery
Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the short-term cognitive changes of patients after surgery.
Measured: The day before surgery and 7 days after surgery (or before leave hospital)
Long-term cognitive changes after surgery
Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the long-term cognitive changes of patients after surgery.
Measured: The day before surgery and 2 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrosis of Femoral HeadStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, diansan su, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220400
- Sponsor's protocol ID
- KPPOCD
- Acronym
- KPPOCD
- Status last verified
- Aug 2014
- First submitted
- 18 Aug 2014
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Ketamine Prevent the Postoperative Cognitive Dysfunction in Aged Patients Underwent Orthopaedic Surgery，a Randomized Control Double Blinded Multicenter Clinical Trail
- ClinicalTrials.gov ID
- NCT02220400
- Acronym / sponsor ID
- KPPOCD / KPPOCD
- Conditions
- Necrosis of Femoral Head, Knee Osteoarthritis
- Keywords
- Postoperative cognitive dysfunction, Ketamine, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 19 Aug 2014 (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.
Previous study demonstrated that neuroinflammation induced by surgery is the main cause of the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved to be an anti-inflammation agent. In present study investigators hypothesized that low dose ketamine would prevent the cognition decline after orthopedic surgery in aged patients.
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 |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineKetamine infusion group |
| Placebo | Placebo comparator | –Normal saline infusion |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elder than 60
- Easily communicated with Chinese
- Selected to kneel or hip replacement
- Agree to take part into this clinical trail
Key exclusion criteria (7 listed)
- Existing cerebral disease， or have a history of neurological and psychiatric disease including AD, stroke and psychosis
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- Several audition or vision disorder
- Preoperative systolic Blood pressure over 190mmHg or diastolic pressure >100mmHg
- Existing a history of hyperthyroidism
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 |
|---|---|---|
| Ketamine | Drug | Ketamine |
Primary outcome
Short-term cognitive changes after surgery
Time frame: The day before surgery and 7 days after surgery (or before leave hospital)
Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the short-term cognitive changes of patients after surgery.
Long-term cognitive changes after surgery
Time frame: The day before surgery and 2 months after surgery
Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the long-term cognitive changes of patients after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 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.
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Necrosis of Femoral Head and Knee Osteoarthritis, run by RenJi Hospital 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 7 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 19 Aug 2014. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term cognitive changes after surgery (time frame: The day before surgery and 7 days after surgery (or before leave hospital)). The study lists 2 primary outcomes in all. 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 19 Aug 2014.