Clinical trial NCT03018522: S100B Protein and Postoperative Cognitive Dysfunction
Official title: S100B Protein as Predictor of Cognitive Dysfunction After Robot-assisted Radical Prostatectomy: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-01-12
Enrollment: 89
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults between 50 and 90 years of age with robot assisted laparoscopic radical prostatectomy , were selected in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score in Neuropsychological Tests
timeFrame: Change from neuropsychological test scores at 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya Training and Research Hospital
name: Nilgun Kavrut Ozturk, M.D.
role: STUDY_DIRECTOR
References:
citation: Silva FP, Schmidt AP, Valentin LS, Pinto KO, Zeferino SP, Oses JP, Wiener CD, Otsuki DA, Tort AB, Portela LV, Souza DO, Auler JO Jr, Carmona MJ. S100B protein and neuron-specific enolase as predictors of cognitive dysfunction after coronary artery bypass graft surgery: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):681-9. doi: 10.1097/EJA.0000000000000450.
citation: Tomaszewski D. Biomarkers of Brain Damage and Postoperative Cognitive Disorders in Orthopedic Patients: An Update. Biomed Res Int. 2015;2015:402959. doi: 10.1155/2015/402959. Epub 2015 Aug 31.
citation: Chen K, Wei P, Zheng Q, Zhou J, Li J. Neuroprotective effects of intravenous lidocaine on early postoperative cognitive dysfunction in elderly patients following spine surgery. Med Sci Monit. 2015 May 15;21:1402-7. doi: 10.12659/MSM.894384.
citation: van Munster BC, Korevaar JC, Korse CM, Bonfrer JM, Zwinderman AH, de Rooij SE. Serum S100B in elderly patients with and without delirium. Int J Geriatr Psychiatry. 2010 Mar;25(3):234-9. doi: 10.1002/gps.2326.
citation: Kavrut Ozturk N, Kavakli AS, Arslan U, Aykal G, Savas M. [S100B level and cognitive dysfunction after robotic-assisted laparoscopic radical prostatectomy procedures: a prospective observational study]. Braz J Anesthesiol. 2020 Nov-Dec;70(6):573-582. doi: 10.1016/j.bjan.2020.06.006. Epub 2020 Oct 15.