Cognitive ImpairmentPhase 4NCT02301676
Long Term Postoperative Cognitive Dysfunction in the Elderly Patients
A Phase 4 study testing Korean version of telephone interview for cognitive status, Sevoflurane and propofol in people with Cognitive Impairment, run by Pusan National University Yangsan Hospital.
Trial summary
The purposes of this study are to determine whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on the result about POCD. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Korean version of telephone interview for cognitive status, Sevoflurane and propofol
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia
Who cannot join
- diseases of the central nervous system, including dementia (Mini Mental Examination Score <24),
- consumption of major tranquilizers or antidepressants
- previous neuropsychological testing
- the patient's inability to comply and follow procedures or poor comprehension of the language used in the study.
- Parkinson's disease
- Patients with a severe visual or auditory handicap, illiteracy
Show all 9Show fewer
- alcoholism (intake of >5 units of alcohol daily during the last 3 months)
- drug dependence
- those not expected to complete the postoperative tests were excluded as well
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase 4 Study of Long Term Postoperative Cognitive Dysfunction After Laparoscopic Cholecystectomy in the Elderly Patients
The purposes of this study are to determine whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on the result about POCD.
Read the detailed description
In present aging society, a surgery in geriatric patient is increasing. Patients older than 60 year are particularly affected for postoperative cognitive dysfunction (POCD) (26-41%). The patients experiencing POCD are at an increased risk of death in the first year after surgery. So, POCD is important because it can influence to patient's quality of life.
In the investigator's hospital, laparoscopic cholecystectomy is performed with increasing frequency in aging patients. So the investigator's study will be conducted in elderly patients during laparoscopic cholecystectomy. The anesthetic methods are divided into the following 3 kinds: sevoflurane, propofol, dexmedetomidine. These anesthetic drugs are used in general anesthesia generally. The control group include a spouse of the patient which must be older than 60 year and does not have anesthetic history.
After the surgery, the patients are discharged from the hospital, the investigators will check the postoperative cognitive function 4 times: 1week, 3months, 6months, 1 year later using the Korean version of telephone interview for cognitive status (TICS). The Korean version of TICS was validated tool for examination of cognitive function and this tool and mini-mental state examination (MMSE) be linked directly. The test will be administered to spouse simultaneously by telephone.
Sample size was calculated for the primary outcome parameters (whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia), and the investigators hypothesized that two groups are in this study, one group is for postanesthetic patients, another is for their spouses. Total sample size was calculated to 190.
- Conditions
- Cognitive Impairment
- Being tested
- Korean version of telephone interview for cognitive status, Sevoflurane, propofol, dexmedetomidine
- Keywords
- Geriatrics; Cognitive impairment; Interviews, Telephone
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Korean version of telephone interview for cognitive statusBehavioural
Also called TICS
The telephone interview for cognitive status (TICS), developed by Brandt et al. (1988), is one of the most popular telephone interview-based screening instruments. Especially, the Korean version of TICS is translated more suitable for Korean culture with the permission of the authors of the original version. The Korean version of TICS consists of 11 items, total score is 41.
SevofluraneDrug
Also called sevofrane
Sevoflurane is one of the most commonly used volatile anesthetic agents, particularly for outpatient anesthesia, and including in anesthesia of children and infants, and in veterinary medicine.
propofolDrug
Also called fresofol
Propofol is highly protein-bound in vivo and is metabolized by conjugation in the liver. The half-life of elimination of propofol has been estimated to be between 2 and 24 hours.
dexmedetomidineDevice
Also called precedex
Dexmedetomidine is a sedative medication used by intensive care units and anesthesiologists. It is relatively unusual in its ability to provide sedation without causing respiratory depression.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia & Control | Active comparator | After the surgery, the patients are discharged from the hospital, investigators will check the postoperative cognitive function 4 times: 1weak, 3months, 6months, 1 year later using the intervention "Korean version of telephone interview for cognitive status (TICS)". The test will be administered to spouse simultaneously by telephone. Receives: Behavioral: Korean version of telephone interview for cognitive status |
| Sevoflurane & Propofol & Dexmedetomidine | Active comparator | The anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally. Receives: Drug: Sevoflurane; Drug: propofol; Device: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
Investigators will assess the postoperative cognitive dysfunction after general anesthesia in elderly patients compare to spouses which have no anesthetic history. Investigators will test participants using the Korean version of TICS and test will be done 1weak, 3months, 6months, 1 year after the surgery.
Measured: two years
Secondary outcomes (1)
The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
Investigators will assess the postoperative cognitive dysfunction (POCD) after general anesthesia (sevoflurane, propofol and dexmedetomidine) and compare the occurrence rate of the POCD in 3 anesthetic methods.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-Jung Kim, Pusan National University Yangsan Hospital
- Investigators
- Seung-Hoon Baek, Study chair, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301676
- Sponsor's protocol ID
- LPOCD60
- Status last verified
- Nov 2014
- First submitted
- 8 Oct 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Long Term Postoperative Cognitive Dysfunction After Laparoscopic Cholecystectomy in the Elderly Patients
- ClinicalTrials.gov ID
- NCT02301676
- Acronym / sponsor ID
- LPOCD60
- Conditions
- Cognitive Impairment
- Keywords
- Geriatrics; Cognitive impairment; Interviews, Telephone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Nov 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.
The purposes of this study are to determine whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia and anesthetic drugs have an effect on the result about POCD.
Detailed description
In present aging society, a surgery in geriatric patient is increasing. Patients older than 60 year are particularly affected for postoperative cognitive dysfunction (POCD) (26-41%). The patients experiencing POCD are at an increased risk of death in the first year after surgery. So, POCD is important because it can influence to patient's quality of life.
In the investigator's hospital, laparoscopic cholecystectomy is performed with increasing frequency in aging patients. So the investigator's study will be conducted in elderly patients during laparoscopic cholecystectomy. The anesthetic methods are divided into the following 3 kinds: sevoflurane, propofol, dexmedetomidine. These anesthetic drugs are used in general anesthesia generally. The control group include a spouse of the patient which must be older than 60 year and does not have anesthetic history.
After the surgery, the patients are discharged from the hospital, the investigators will check the postoperative cognitive function 4 times: 1week, 3months, 6months, 1 year later using the Korean version of telephone interview for cognitive status (TICS). The Korean version of TICS was validated tool for examination of cognitive function and this tool and mini-mental state examination (MMSE) be linked directly. The test will be administered to spouse simultaneously by telephone.
Sample size was calculated for the primary outcome parameters (whether long-term postoperative cognitive dysfunction (POCD) is occured after general anesthesia), and the investigators hypothesized that two groups are in this study, one group is for postanesthetic patients, another is for their spouses. Total sample size was calculated to 190.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia & Control | Active comparator | Behavioral: Korean version of telephone interview for cognitive statusAfter the surgery, the patients are discharged from the hospital, investigators will check the postoperative cognitive function 4 times: 1weak, 3months, 6months, 1 year later using the intervention "Korean version of telephone interview for cognitive status (TICS)". The test will be administered to spouse simultaneously by telephone. |
| Sevoflurane & Propofol & Dexmedetomidine | Active comparator | Drug: Sevoflurane, Drug: propofol, Device: dexmedetomidineThe anesthetic methods are divided into the following 3 kinds: Sevoflurane, Propofol, Dexmedetomidine. These anesthetic drugs are used in general anesthesia generally. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 60 years old, scheduled for laparoscopic cholecystectomy under general anesthesia
Key exclusion criteria (9 listed)
- diseases of the central nervous system, including dementia (Mini Mental Examination Score <24),
- consumption of major tranquilizers or antidepressants
- previous neuropsychological testing
- the patient's inability to comply and follow procedures or poor comprehension of the language used in the study.
- Parkinson's disease
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 |
|---|---|---|
| Korean version of telephone interview for cognitive statusAlso: TICSThe telephone interview for cognitive status (TICS), developed by Brandt et al. (1988), is one of the most popular telephone interview-based screening instruments. Especially, the Korean version of TICS is translated more suitable for Korean culture with the permission of the authors of the original version. The Korean version of TICS consists of 11 items, total score is 41. | Behavioural | General anesthesia & Control |
| SevofluraneAlso: sevofraneSevoflurane is one of the most commonly used volatile anesthetic agents, particularly for outpatient anesthesia, and including in anesthesia of children and infants, and in veterinary medicine. | Drug | Sevoflurane & Propofol & Dexmedetomidine |
| propofolAlso: fresofolPropofol is highly protein-bound in vivo and is metabolized by conjugation in the liver. The half-life of elimination of propofol has been estimated to be between 2 and 24 hours. | Drug | Sevoflurane & Propofol & Dexmedetomidine |
| dexmedetomidineAlso: precedexDexmedetomidine is a sedative medication used by intensive care units and anesthesiologists. It is relatively unusual in its ability to provide sedation without causing respiratory depression. | Device | Sevoflurane & Propofol & Dexmedetomidine |
Primary outcome
The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients.
Time frame: two years
Investigators will assess the postoperative cognitive dysfunction after general anesthesia in elderly patients compare to spouses which have no anesthetic history. Investigators will test participants using the Korean version of TICS and test will be done 1weak, 3months, 6months, 1 year after the surgery.
1 secondary outcome
The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
Related trials for Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingObservational study
Perception of Action Opportunities for Obstacle Crossing in Parkinson's Disease
PARKINSON DISEASE (Disorder), Older Adults (65-85 Years)
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.
Seung-Hoon Baek study chair
Pusan National University Yangsan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Korean version of telephone interview for cognitive status, Sevoflurane and propofol in people with Cognitive Impairment, run by Pusan National University Yangsan Hospital.
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 1 inclusion and 9 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 Eun-Jung Kim (821025137881, kejdream@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients. (time frame: two years). 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 2 Dec 2014.