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S100B Protein and Postoperative Cognitive Dysfunction

S100B Protein as Predictor of Cognitive Dysfunction After Robot-assisted Radical Prostatectomy: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03018522
Enrollment
89
Registered
2017-01-12
Start date
2017-02-14
Completion date
2018-02-14
Last updated
2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Brief summary

Primary aim of this study is to evaluate the association between postoperative cognitive dysfunction and increased serum levels of S100B protein after robot-assisted laparoscopic radical prostatectomy.

Detailed description

The neurocognitive assessment protocol will design to evaluate general cognitive function and identify patients with cognitive dysfunction. Neuropsychological tests of all patients will conduct on the one day prior to surgery, the seventh day after surgery, and the 3rd month after surgery, respectively. According to a consensus statement, cognitive function will assess using a battery of seven neuropsychological tests: Rey Auditory Verbal Learning Test (delayed recall), Trail Making Test (Parts A and B), Digit Span Test (forward and backward), and Grooved Pegboard Test (dominant and non-dominant hands). To determine a normal reference value of cognitive functions, a group of 20 healthy individuals appropriately selected with respect to sex, age and education level without any significant mental or somatic disorders and without operation were recruited as a control group. To determine the cognitive dysfunction, baseline score or time measurement were subtracted from test score and the difference was divided by the standard deviation of the score in the control group. The result was called the Z score. Z score was calculated for each test and, POCD was defined as a Z score greater than 1.96 in at least two of the seven tests, and/or a combined Z score greater than 1.96. Serum levels of S100B protein will obtain from venous blood samples collected before surgery, after anesthesia induction, at 30 min and 24 h after surgery.

Interventions

OTHERPostoperative cognitive dysfunction

Neuropsychological tests of all patients will conduct on the one day prior to surgery, the 7th day after surgery, and the 3rd month after surgery

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* over 50 years old * scheduled for robotic-assisted laparoscopic radical prostatectomy * the body mass index ranged from 18 kg/m2 to 25 kg/m2 * American Society of Anesthesiologists class I, II or III

Exclusion criteria

* Patients with previous neurological deficit (symptomatic stroke, hemorrhage, transient ischemic attack) * other neurologic disorders (epilepsy, trauma, intra- or extracranial malignancy) * psychiatric diseases (schizophrenia, or depressive disorder) * alcoholism or any other drug dependence * serious hearing or visual impairment

Design outcomes

Primary

MeasureTime frameDescription
Score in Neuropsychological TestsChange from neuropsychological test scores at 3 months.This assessment will be applied before surgery, and 7 days and 3 months after surgery.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026