Cognitive DeclineNCT03775343
Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery
An observational study of Cognitive Decline, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This project will investigate changes in cognitive function in the early postoperative phase (<24 hours) after minor surgery in patients of older age (≥65 years). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Neurocognitive Test Battery and Blood sampling
- How many people
- 75 participants
- Where
- 1 siteAustria
- Study dates
- 6 Oct 2018to 30 Aug 2023
- 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
- Healthy volunteers accepted
- Older adult
Study population: 50 patients 65 years and older without any significant mental (MMSE ≥24) or neuropsychiatric disorders scheduled for elective ocular surgery requiring general anaesthesia or sedoanalgesia will be undergoing serial cognitive assessements pre- and postoperatively over 3 time-points. To determine a normal reference value of cognitive functions, a group of 25 participants in the same age (≥65 years)and without surgical intervention will be recruited as a control group and undergo serial cognitive assessements over 3 time-points.
Who may be able to join
- Patients age 65 and older
- scheduled to undergo elective ocular surgery
- American Society of Anesthesiologists class I, II or III
- MMSE score ≥ 24
- The people signed informed consent.
- Expected surgical duration <90 minutes
- Able to follow study instructions.
Who cannot join
- Patients age < 65 years
- Emergent nature of the ocular surgery
- American Society of Anesthesiologists class IV
- MMSE score < 24
- unsigned informed consent
- Expected surgical duration >90 minutes
Show all 9Show fewer
- Not able to follow study instructions.
- History of psychiatric or neurologic disorders (epilepsy, trauma, stroke,depressive disorders, hemorrhage, transient ischemic attack
- Drug or substance abuse history
Trial locations and contacts
1 site in 1 country.
About this study
This project will investigate changes in cognitive function in the early postoperative phase (<24 hours) after minor surgery in patients of older age (≥65 years).
Read the detailed description
Primary aim of this study is to evaluate changes in cognitive function in the early postoperative phase after minor surgery in patients of older age (≥65 years).
Background: Postoperative cognitive dysfunction can be a serious complication after surgery and is associated with higher mortality.Several studies have demonstrated that major surgery and patients of older age are risk factors for the incidence of cognitive decline in the postoperative phase. Only a few studies investigated the early postoperative changes in cognitive function (< 24 hours) after minor, day case surgeries in older patients (≥65 years), demonstrating a higher incidence than observed ≥1 week after surgery.
Aim of the project: This study aimed to investigate changes in cognitive function after minor surgery in an elderly patient cohort.
It is the effort to plan perioperative care that can reduce the incidence of postoperative cognitive dysfunction in elderly.
Hypothesis: The present study support the hypothesis that changes in cognitive function after ocular surgery will be greater in the general anesthesia group compared to the sedoanalgesia group.
Methods:
The study will be conducted as a single center, prospective, observational controlled trial at the Medical University of Vienna, Austria.
This prospective and observational study involves consecutive elderly patients (≥65 years) undergoing a minor surgery using general anesthesia or local anesthesia with sedoanalgesia. Fifty patients, 65 years and older, scheduled for elective minor ocular surgery and 25 participants as control group without surgical intervention will be recruited.
Enrollees will be divided in 3 groups:
25 patients general anaesthesia (GA), 25 patients sedoanalgesia combined with local anaesthesia (SA) and 25 participants as control group(CO) without surgical intervention.
Anesthesia will be induced in a standardized fashion in both groups (GA,SA). At baseline the performance on neurocognitive testing using the Mini Mental State Examination (MMSE) hast to be ≥24, otherwise participants will be excluded.
The design utilizes prospective serial assessments of cognitive status. The participants will be evaluated preoperatively and postoperatively over 3 time-points (preoperatively, 6 and 24 hours after surgery) using the Neurocognitive Test Battery Vienna (NTBV) for cognitive assessment.
At the same time points blood tests for plasma levels of S 100-B, IL-6, CRP, vitamin B 12, vitamin D, homocysteine and folic acid will be taken.
This project will investigate the correlation between perioperative changes in these serum parameters with neurocognitive outcome in the elderly after minor surgery to explore whether the concentrations of these parameters can be used as predictors of postoperative cognitive dysfunction and to provide reference for postoperative cognitive dysfunction prevention, early detection and timely diagnosis and treatment.
Further purpose of this study is to investigate if there is an association between changes in intraoperative cerebral oxygenation, changes in perioperative blood pressure, depth of anaesthesia and the presence of cognitive deterioration after surgery.
It is the effort to plan perioperative care that can reduce the incidence of postoperative changes in cognitive function.
- Conditions
- Cognitive Decline
- Being tested
- Neurocognitive Test Battery, Blood sampling
- Keywords
- Anesthesia, Postoperative cognitive decline
- Medical subject headings
- Cognitive Dysfunction, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive Test BatteryDiagnostic test
neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.
Blood samplingDiagnostic test
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | General anesthesia:
25 patients older than 65 years, undergoing elective eye surgery under general anesthesia.
Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative.
Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery. Receives: Diagnostic Test: Neurocognitive Test Battery; Diagnostic Test: Blood sampling | |
| Local anesthesia with sedoanalgesia | 25 patients older than 65 years, undergoing elective eye surgery under local anesthesia in combination with sedoanalgesia.
Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery. Receives: Diagnostic Test: Neurocognitive Test Battery; Diagnostic Test: Blood sampling | |
| Control Group | 25 patients, not undergoing any operative intervention. To determine a normal reference value of cognitive functions, a group of 25 individuals without an operative intervention will be recruited as a control group.
Intervention: neurocognitive testing (Neurocognitive Test Battery) at 3 determined time points (0, 6 and 24 hours) Receives: Diagnostic Test: Neurocognitive Test Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Test Battery Vienna (NTBV)
The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test to assess a broad range of cognitive abilities.(Lehrner J., 2007) It was created to detect cognitive impairment in Alzheimer's Disease (Lehrner J., 2007). The investigators will investigate changes in NTBV between baseline compared to 24 hour after minor surgery using regression based z-score analyses (-1,5 - + 1,5 standard deviation(SD) ; > -1,5 SD indicating a larger decline in cognitive function).
Measured: before surgery (baseline) and 24 hours after surgery
Secondary outcomes (1)
Neuropsychological Test Battery Vienna (NTBV)
The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test. (Lehrner J., 2007)
Measured: before surgery(baseline) and 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start6 Oct 2018
- Primary completion28 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marita Windpassinger M.D., Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775343
- Sponsor's protocol ID
- 1907/2017
- Status last verified
- Aug 2023
- First submitted
- 26 Oct 2018
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Publications
Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
Foki T, Hitzl D, Pirker W, Novak K, Pusswald G, Auff E, Lehrner J. Erratum to: Assessment of individual cognitive changes after deep brain stimulation surgery in Parkinson's disease using the Neuropsychological Test Battery Vienna short version. Wien Klin Wochenschr. 2017 Aug;129(15-16):585-587. doi: 10.1007/s00508-017-1210-2. No abstract available.
PubMed 28741045
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Cognitive Impairment in Elderly Patients Following Ocular Surgery
- ClinicalTrials.gov ID
- NCT03775343
- Acronym / sponsor ID
- 1907/2017
- Conditions
- Cognitive Decline
- Keywords
- Anesthesia, Postoperative cognitive decline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 6 Oct 2018 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 13 Dec 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.
This project will investigate changes in cognitive function in the early postoperative phase (<24 hours) after minor surgery in patients of older age (≥65 years).
Detailed description
Primary aim of this study is to evaluate changes in cognitive function in the early postoperative phase after minor surgery in patients of older age (≥65 years).
Background: Postoperative cognitive dysfunction can be a serious complication after surgery and is associated with higher mortality.Several studies have demonstrated that major surgery and patients of older age are risk factors for the incidence of cognitive decline in the postoperative phase. Only a few studies investigated the early postoperative changes in cognitive function (< 24 hours) after minor, day case surgeries in older patients (≥65 years), demonstrating a higher incidence than observed ≥1 week after surgery.
Aim of the project: This study aimed to investigate changes in cognitive function after minor surgery in an elderly patient cohort.
It is the effort to plan perioperative care that can reduce the incidence of postoperative cognitive dysfunction in elderly.
Hypothesis: The present study support the hypothesis that changes in cognitive function after ocular surgery will be greater in the general anesthesia group compared to the sedoanalgesia group.
Methods:
The study will be conducted as a single center, prospective, observational controlled trial at the Medical University of Vienna, Austria.
This prospective and observational study involves consecutive elderly patients (≥65 years) undergoing a minor surgery using general anesthesia or local anesthesia with sedoanalgesia. Fifty patients, 65 years and older, scheduled for elective minor ocular surgery and 25 participants as control group without surgical intervention will be recruited.
Enrollees will be divided in 3 groups:
25 patients general anaesthesia (GA), 25 patients sedoanalgesia combined with local anaesthesia (SA) and 25 participants as control group(CO) without surgical intervention.
Anesthesia will be induced in a standardized fashion in both groups (GA,SA). At baseline the performance on neurocognitive testing using the Mini Mental State Examination (MMSE) hast to be ≥24, otherwise participants will be excluded.
The design utilizes prospective serial assessments of cognitive status. The participants will be evaluated preoperatively and postoperatively over 3 time-points (preoperatively, 6 and 24 hours after surgery) using the Neurocognitive Test Battery Vienna (NTBV) for cognitive assessment.
At the same time points blood tests for plasma levels of S 100-B, IL-6, CRP, vitamin B 12, vitamin D, homocysteine and folic acid will be taken.
This project will investigate the correlation between perioperative changes in these serum parameters with neurocognitive outcome in the elderly after minor surgery to explore whether the concentrations of these parameters can be used as predictors of postoperative cognitive dysfunction and to provide reference for postoperative cognitive dysfunction prevention, early detection and timely diagnosis and treatment.
Further purpose of this study is to investigate if there is an association between changes in intraoperative cerebral oxygenation, changes in perioperative blood pressure, depth of anaesthesia and the presence of cognitive deterioration after surgery.
It is the effort to plan perioperative care that can reduce the incidence of postoperative changes in cognitive function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | Diagnostic Test: Neurocognitive Test Battery, Diagnostic Test: Blood samplingGeneral anesthesia: 25 patients older than 65 years, undergoing elective eye surgery under general anesthesia. Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative. Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery. |
| Local anesthesia with sedoanalgesia | – | Diagnostic Test: Neurocognitive Test Battery, Diagnostic Test: Blood sampling25 patients older than 65 years, undergoing elective eye surgery under local anesthesia in combination with sedoanalgesia. Intervention: neurocognitive testing (Neurocognitive Test Battery) preoperative, 6 and 24 hours postoperative Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery. |
| Control Group | – | Diagnostic Test: Neurocognitive Test Battery25 patients, not undergoing any operative intervention. To determine a normal reference value of cognitive functions, a group of 25 individuals without an operative intervention will be recruited as a control group. Intervention: neurocognitive testing (Neurocognitive Test Battery) at 3 determined time points (0, 6 and 24 hours) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 50 patients 65 years and older without any significant mental (MMSE ≥24) or neuropsychiatric disorders scheduled for elective ocular surgery requiring general anaesthesia or sedoanalgesia will be undergoing serial cognitive assessements pre- and postoperatively over 3 time-points. To determine a normal reference value of cognitive functions, a group of 25 participants in the same age (≥65 years)and without surgical intervention will be recruited as a control group and undergo serial cognitive assessements over 3 time-points.
Key inclusion criteria (7 listed)
- Patients age 65 and older
- scheduled to undergo elective ocular surgery
- American Society of Anesthesiologists class I, II or III
- MMSE score ≥ 24
- The people signed informed consent.
Key exclusion criteria (9 listed)
- Patients age < 65 years
- Emergent nature of the ocular surgery
- American Society of Anesthesiologists class IV
- MMSE score < 24
- unsigned informed consent
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 |
|---|---|---|
| Neurocognitive Test Batteryneurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative. | Diagnostic test | Control Group, General Anesthesia, Local anesthesia with sedoanalgesia |
| Blood samplingBlood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid | Diagnostic test | General Anesthesia, Local anesthesia with sedoanalgesia |
Primary outcome
Neuropsychological Test Battery Vienna (NTBV)
Time frame: before surgery (baseline) and 24 hours after surgery
The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test to assess a broad range of cognitive abilities.(Lehrner J., 2007) It was created to detect cognitive impairment in Alzheimer's Disease (Lehrner J., 2007). The investigators will investigate changes in NTBV between baseline compared to 24 hour after minor surgery using regression based z-score analyses (-1,5 - + 1,5 standard deviation(SD) ; > -1,5 SD indicating a larger decline in cognitive function).
1 secondary outcome
Neuropsychological Test Battery Vienna (NTBV)
Time frame: before surgery(baseline) and 6 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- BackgroundLehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
- Background: PubMed 28741045Foki T, Hitzl D, Pirker W, Novak K, Pusswald G, Auff E, Lehrner J. Erratum to: Assessment of individual cognitive changes after deep brain stimulation surgery in Parkinson's disease using the Neuropsychological Test Battery Vienna short version. Wien Klin Wochenschr. 2017 Aug;129(15-16):585-587. doi: 10.1007/s00508-017-1210-2. No abstract available.
- The Neuropsychological Test Battery Vienna (NTBV)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. not yet decided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline, run by Medical University of Vienna at 1 site in Austria.
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 7 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: finished, as of the sponsor's last update on 30 Aug 2023. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Test Battery Vienna (NTBV) (time frame: before surgery (baseline) and 24 hours after surgery). 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 NCT03775343, which also lists 2 linked publications.
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 30 Aug 2023.