Early Postoperative Cognitive Changes in Older Adults Undergoing Total Knee Arthroplasty: A Comparison of General and Spinal Anesthesia
Sponsor study identifier
observational
44
1 country
1
Study Start
October 15, 2024
Actual (reported)Primary Completion
February 10, 2025
Actual (reported)Study Completion
February 10, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 10, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2024
Actual (reported)February 10, 2025
Actual (reported)February 10, 2025
Actual (reported)October 1, 2026
Actual (reported)October 6, 2026
Actual (reported)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.
Preoperative baseline to 24 hours postoperatively
Change in serum S100B concentration from baseline to 6 hours postoperatively
Preoperative baseline to 6 hours postoperatively
Change in serum S100B concentration from baseline to 24 hours postoperatively
Preoperative baseline to 24 hours postoperatively Secondary Outcome 3
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.
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.
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.
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Administration procedure
Spinal Anesthesia with Bupivacaine
The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.
View registry recordThe 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.
Sultangazi Haseki Training and Research Hospital
Istanbul, 34265, Turkey (Türkiye)
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.
44 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2026
First Posted
October 6, 2026
Study Start
October 15, 2024
Actual (reported)Acute Effects of Moderate Intensity Aerobic Exercise on Cognitive Functions in Young Adult Males
Association between postoperative changes in serum S100B concentration and changes in MMSE score
Preoperative baseline to 24 hours postoperatively
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.
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Primary Completion
February 10, 2025
Actual (reported)Study Completion
February 10, 2025
Actual (reported)Last Updated
October 6, 2026
Record last verified: 2026-10
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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Source: ClinicalTrials.gov.
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