Cognitive ChangeNCT07860593
Early Cognitive Changes After General Versus Spinal Anesthesia in Older Adults Undergoing Total Knee Arthroplasty
An observational study of Cognitive Change and Total Knee Anthroplasty, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study investigated early postoperative cognitive changes in older adults undergoing elective total knee arthroplasty under general or spinal anesthesia. Patients aged 65 years or older who were considered suitable for either anesthetic technique were prospectively enrolled. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Change, Total Knee Anthroplasty
- What is being tested?
- General Anesthesia and Spinal Anesthesia with Bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 10 Feb 2025
- 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: The study population consisted of consecutive patients aged 65 years or older who were scheduled for elective total knee arthroplasty at Sultangazi Haseki Training and Research Hospital, Istanbul, Türkiye. Eligible patients were prospectively screened before anesthesia and included if they were considered clinically suitable for either general or spinal anesthesia. Patients were subsequently classified according to the anesthetic technique used during surgery, which was determined as part of routine clinical care based on patient preference, clinical characteristics, surgical considerations, and the attending anesthesiologist's judgment.
Who may be able to join
- Age ≥65 years.
- Scheduled for elective total knee arthroplasty.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Considered clinically suitable for either general or spinal anesthesia.
- Preoperative Mini-Mental State Examination (MMSE) score ≥24.
- Physically and cognitively able to complete the study assessments.
- Provided written informed consent.
Who cannot join
- Previously diagnosed neurocognitive disorder or dementia.
- History of cerebrovascular disease associated with persistent neurological impairment.
- Neurological or psychiatric disorder that could interfere with cognitive assessment.
- Cardiac, respiratory, hepatic, or renal failure.
- Severe visual or hearing impairment preventing completion of the MMSE.
- Contraindication to either general or spinal anesthesia.
- Inability to complete the perioperative study protocol.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultangazi Haseki Training and Research Hospital
Istanbul, 34265
About this study
Official title: Early Postoperative Cognitive Changes in Older Adults Undergoing Total Knee Arthroplasty: A Comparison of General and Spinal Anesthesia
This prospective observational study investigated early postoperative cognitive changes in older adults undergoing elective total knee arthroplasty under general or spinal anesthesia. Patients aged 65 years or older who were considered suitable for either anesthetic technique were prospectively enrolled. The anesthetic technique was determined according to patient preference, clinical characteristics, surgical considerations, and the attending anesthesiologist's judgment and was not assigned by the investigators.
Cognitive function was assessed using the Mini-Mental State Examination (MMSE) preoperatively and 24 h after surgery. Serum S100B concentrations were measured preoperatively and at 6 and 24 h postoperatively. The primary objective was to compare changes in MMSE scores between the general and spinal anesthesia groups. Secondary objectives were to compare perioperative changes in serum S100B concentrations and to evaluate their association with postoperative changes in cognitive performance.
- Conditions
- Cognitive Change, Total Knee Anthroplasty
- Being tested
- General Anesthesia, Spinal Anesthesia with Bupivacaine
- Keywords
- Total knee arthroplasty, general anesthesia, spinal anesthesia, Mini-Mental State Examination, cognitive change, Perioperative neurocognitive disorders, S100B, older patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaProcedure or surgery
General anesthesia was administered as part of routine clinical care. Anesthesia was induced with intravenous fentanyl (1 μg/kg) and propofol (1.5-2 mg/kg), and neuromuscular blockade was achieved with rocuronium (0.6 mg/kg). Following endotracheal intubation, anesthesia was maintained with sevoflurane at a target end-tidal concentration corresponding to approximately 1.2 minimum alveolar concentration (MAC). The anesthetic technique was selected according to patient preference, clinical characteristics, surgical considerations, and the attending anesthesiologist's judgment and was not assigned by the study investigators.
Spinal Anesthesia with BupivacaineProcedure or surgery
Spinal anesthesia was administered as part of routine clinical care. After identification of the L4-L5 interspace, 15 mg of 0.5% hyperbaric bupivacaine was administered intrathecally using a 25-gauge Whitacre spinal needle. Surgery was initiated after confirmation of an adequate sensory block reaching at least the T10 dermatome. The anesthetic technique was selected according to patient preference, clinical characteristics, surgical considerations, and the attending anesthesiologist's judgment and was not assigned by the study investigators.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Older adults undergoing elective total knee arthroplasty under general anesthesia. The anesthetic technique was selected according to routine clinical practice and was not assigned by the investigators. Receives: Procedure: General Anesthesia | |
| Spinal anesthesia | Older adults undergoing elective total knee arthroplasty under spinal anesthesia. The anesthetic technique was selected according to routine clinical practice and was not assigned by the investigators. Receives: Procedure: Spinal Anesthesia with Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mini-Mental State Examination (MMSE) score
Cognitive function was assessed using the 30-point MMSE. Change in cognitive performance was calculated as the postoperative 24-h MMSE score minus the preoperative baseline MMSE score. Negative values indicated a decline in cognitive performance.
Measured: Preoperative baseline to 24 hours postoperatively
Secondary outcomes (3)
Change in serum S100B concentration from baseline to 6 hours postoperatively
Measured: Preoperative baseline to 6 hours postoperatively
Change in serum S100B concentration from baseline to 24 hours postoperatively
Measured: Preoperative baseline to 24 hours postoperatively Secondary Outcome 3
Association between postoperative changes in serum S100B concentration and changes in MMSE score
Measured: Preoperative baseline to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Oct 2024
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
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 Cognitive ChangeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Uzman, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860593
- Sponsor's protocol ID
- 2-20240
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article may be made available upon reasonable request to the corresponding author. Data will be shared with qualified researchers for scientifically valid purposes, subject to appropriate institutional and ethical requirements and a data-sharing agreement where applicable.
Publications
Rietmeijer CA. The role of STD outreach testing in times of dwindling STD prevention resources. Sex Transm Dis. 2003 Aug;30(8):659-60. doi: 10.1097/01.OLQ.0000083893.96048.F4. No abstract available.
PubMed 12897690
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Cognitive Changes in Older Adults Undergoing Total Knee Arthroplasty: A Comparison of General and Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07860593
- Acronym / sponsor ID
- 2-20240
- Conditions
- Cognitive Change, Total Knee Anthroplasty
- Keywords
- Total knee arthroplasty, general anesthesia, spinal anesthesia, Mini-Mental State Examination, cognitive change, Perioperative neurocognitive disorders, S100B, older patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 6 Oct 2026 (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 prospective observational study investigated early postoperative cognitive changes in older adults undergoing elective total knee arthroplasty under general or spinal anesthesia. Patients aged 65 years or older who were considered suitable for either anesthetic technique were prospectively enrolled. The anesthetic technique was determined according to patient preference, clinical characteristics, surgical considerations, and the attending anesthesiologist's judgment and was not assigned by the investigators.
Cognitive function was assessed using the Mini-Mental State Examination (MMSE) preoperatively and 24 h after surgery. Serum S100B concentrations were measured preoperatively and at 6 and 24 h postoperatively. The primary objective was to compare changes in MMSE scores between the general and spinal anesthesia groups. Secondary objectives were to compare perioperative changes in serum S100B concentrations and to evaluate their association with postoperative changes in cognitive performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | Procedure: General AnesthesiaOlder adults undergoing elective total knee arthroplasty under general anesthesia. The anesthetic technique was selected according to routine clinical practice and was not assigned by the investigators. |
| Spinal anesthesia | – | Procedure: Spinal Anesthesia with BupivacaineOlder adults undergoing elective total knee arthroplasty under spinal anesthesia. The anesthetic technique was selected according to routine clinical practice and was not assigned by the investigators. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consisted of consecutive patients aged 65 years or older who were scheduled for elective total knee arthroplasty at Sultangazi Haseki Training and Research Hospital, Istanbul, Türkiye. Eligible patients were prospectively screened before anesthesia and included if they were considered clinically suitable for either general or spinal anesthesia. Patients were subsequently classified according to the anesthetic technique used during surgery, which was determined as part of routine clinical care based on patient preference, clinical characteristics, surgical considerations, and the attending anesthesiologist's judgment.
Key inclusion criteria (7 listed)
- Age ≥65 years.
- Scheduled for elective total knee arthroplasty.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Considered clinically suitable for either general or spinal anesthesia.
- Preoperative Mini-Mental State Examination (MMSE) score ≥24.
Key exclusion criteria (7 listed)
- Previously diagnosed neurocognitive disorder or dementia.
- History of cerebrovascular disease associated with persistent neurological impairment.
- Neurological or psychiatric disorder that could interfere with cognitive assessment.
- Cardiac, respiratory, hepatic, or renal failure.
- Severe visual or hearing impairment preventing completion of the MMSE.
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 |
|---|---|---|
| General AnesthesiaGeneral anesthesia was administered as part of routine clinical care. Anesthesia was induced with intravenous fentanyl (1 μg/kg) and propofol (1.5-2 mg/kg), and neuromuscular blockade was achieved with rocuronium (0.6 mg/kg). Following endotracheal intubation, anesthesia was maintained with sevoflurane at a target end-tidal concentration corresponding to approximately 1.2 minimum alveolar concentration (MAC). The anesthetic technique was selected according to patient preference, clinical characteristics, surgical considerations, and the attending anesthesiologist's judgment and was not assigned by the study investigators. | Procedure or surgery | General anesthesia |
| Spinal Anesthesia with BupivacaineSpinal anesthesia was administered as part of routine clinical care. After identification of the L4-L5 interspace, 15 mg of 0.5% hyperbaric bupivacaine was administered intrathecally using a 25-gauge Whitacre spinal needle. Surgery was initiated after confirmation of an adequate sensory block reaching at least the T10 dermatome. The anesthetic technique was selected according to patient preference, clinical characteristics, surgical considerations, and the attending anesthesiologist's judgment and was not assigned by the study investigators. | Procedure or surgery | Spinal anesthesia |
Primary outcome
Change in Mini-Mental State Examination (MMSE) score
Time frame: Preoperative baseline to 24 hours postoperatively
Cognitive function was assessed using the 30-point MMSE. Change in cognitive performance was calculated as the postoperative 24-h MMSE score minus the preoperative baseline MMSE score. Negative values indicated a decline in cognitive performance.
3 secondary outcomes
Change in serum S100B concentration from baseline to 6 hours postoperatively
Time frame: Preoperative baseline to 6 hours postoperatively
Change in serum S100B concentration from baseline to 24 hours postoperatively
Time frame: Preoperative baseline to 24 hours postoperatively Secondary Outcome 3
Association between postoperative changes in serum S100B concentration and changes in MMSE score
Time frame: Preoperative baseline to 24 hours postoperatively
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 6 Oct 2026.
- Background: PubMed 12897690Rietmeijer CA. The role of STD outreach testing in times of dwindling STD prevention resources. Sex Transm Dis. 2003 Aug;30(8):659-60. doi: 10.1097/01.OLQ.0000083893.96048.F4. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article may be made available upon reasonable request to the corresponding author. Data will be shared with qualified researchers for scientifically valid purposes, subject to appropriate institutional and ethical requirements and a data-sharing agreement where applicable.
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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 Change and Total Knee Anthroplasty, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 6 Oct 2026. 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 Turkey (Türkiye). 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?
Change in Mini-Mental State Examination (MMSE) score (time frame: Preoperative baseline to 24 hours postoperatively). 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 NCT07860593, 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 6 Oct 2026.