Postoperative Cognitive DysfunctionNCT03393676
Preoperative Pain and POCD in Elderly Patients
An observational study of Postoperative Cognitive Dysfunction, run by RenJi Hospital at 2 sites in China.
Trial summary
The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 10 Jan 2018to 31 Mar 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients underwent elective low limb surgery(hemiarthroplasty or total hip arthroplasty); Chronic pain duration >3 months.
Who may be able to join
- Elder than 65 years old
- Speak Chinese Mandarin
- Those who will undergo major low limb surgery like hemiarthroplasty or total hip arthroplasty with general anesthesia.
- Signed the inform consent
- American Society of Anesthesiologists classification I to II
Who cannot join
- Existing cerebral disease, or have a history of neurological and psychiatric disease including Alzheimer Disease, stroke, epilepsy and psychosis
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- Severe hearing or visual impairment
- Unwillingness to comply with the protocol or procedures
- Cannot communicate with Chinese Mandarin
- Serious pulmonary, heart , liver or renal insufficiency patients
- Had anesthesia or surgery within the past 30 days
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Reni Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
Xiaorong Huai, MS, 13818003683, smile_huai@126.com
Diansan Su, MD, 18616514088, diansansu@163.com
- Recruiting
Shanghai Ren ji Hospital
Shanghai, Shanghai Municipality, 200127
Xiaorong Huai, MS, +8613818003683, smile_huai@126.com
Diansan Su, MD, +8618616514088, diansansu@yahoo.com
About this study
Official title: Preoperative Chronic Pain Increases the Risk of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: a Prospective Observational Cohort Study
The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients.
Read the detailed description
Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. The mechanism of POCD is not clear yet and no effective therapy method. In the present study, we conducted a single-center observational prospective cohort trial in elder patients who undergoing hip joint replacement surgery with general anesthesia to test our hypothesis that preoperative chronic pain is one of the risk factors of POCD after major joint replacement surgery.
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Postoperative Cognitive Dysfunction, elderly patients, Preoperative Pain
- Medical subject headings
- Postoperative Cognitive Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
POCD incidence 7 days (or before leaving hospital) after surgery
POCD incidence 7 days (or before leaving hospital) after surgery
Measured: 7 days (or before leaving hospital)
Secondary outcomes (1)
POCD incidence 2 months after surgery
POCD incidence 2 months after surgery
Measured: 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 posted8 Jan 2018
- Study start10 Jan 2018
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
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 Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Huai, RenJi Hospital
- Investigators
- Weifeng Yu, MD, Study chair, Anesthesiology Department Renji Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393676
- Sponsor's protocol ID
- PPOCD20161201
- Status last verified
- Mar 2020
- First submitted
- 26 Dec 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huai X, Jiao Y, Gu X, Zhu H, Chen L, Fan Y, Yu W, Su D, Xie H. Preoperative Chronic Pain as a Risk Factor for Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: A Prospective Observational Cohort Study. Front Neurosci. 2021 Dec 17;15:747362. doi: 10.3389/fnins.2021.747362. eCollection 2021.
PubMed 34975369
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Chronic Pain Increases the Risk of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03393676
- Acronym / sponsor ID
- PPOCD20161201
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Postoperative Cognitive Dysfunction, elderly patients, Preoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 8 Jan 2018 (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.
The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients.
Detailed description
Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. The mechanism of POCD is not clear yet and no effective therapy method. In the present study, we conducted a single-center observational prospective cohort trial in elder patients who undergoing hip joint replacement surgery with general anesthesia to test our hypothesis that preoperative chronic pain is one of the risk factors of POCD after major joint replacement surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients underwent elective low limb surgery(hemiarthroplasty or total hip arthroplasty); Chronic pain duration >3 months.
Key inclusion criteria (5 listed)
- Elder than 65 years old
- Speak Chinese Mandarin
- Those who will undergo major low limb surgery like hemiarthroplasty or total hip arthroplasty with general anesthesia.
- Signed the inform consent
- American Society of Anesthesiologists classification I to II
Key exclusion criteria (7 listed)
- Existing cerebral disease, or have a history of neurological and psychiatric disease including Alzheimer Disease, stroke, epilepsy and psychosis
- Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- Severe hearing or visual impairment
- Unwillingness to comply with the protocol or procedures
- Cannot communicate with Chinese Mandarin
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
POCD incidence 7 days (or before leaving hospital) after surgery
Time frame: 7 days (or before leaving hospital)
POCD incidence 7 days (or before leaving hospital) after surgery
1 secondary outcome
POCD incidence 2 months after surgery
Time frame: 2 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 34975369Huai X, Jiao Y, Gu X, Zhu H, Chen L, Fan Y, Yu W, Su D, Xie H. Preoperative Chronic Pain as a Risk Factor for Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: A Prospective Observational Cohort Study. Front Neurosci. 2021 Dec 17;15:747362. doi: 10.3389/fnins.2021.747362. eCollection 2021.
Related trials for Postoperative Cognitive Dysfunction
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Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
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The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
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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.
Weifeng Yu, MD study chair
Anesthesiology Department Renji Hospital, Shanghai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Dysfunction, run by RenJi Hospital at 2 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 5 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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 Xiaorong Huai, MS (13818003683, smile_huai@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POCD incidence 7 days (or before leaving hospital) after surgery (time frame: 7 days (or before leaving hospital)). 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 NCT03393676, 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 10 Mar 2020.