Clinical Trials Directory

Trials / Completed

CompletedNCT03018522

S100B Protein and Postoperative Cognitive Dysfunction

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

Status
Completed
Phase
Study type
Observational
Enrollment
89 (actual)
Sponsor
Antalya Training and Research Hospital · Other Government
Sex
Male
Age
50 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2017-02-14
Primary completion
2017-11-24
Completion
2018-02-14
First posted
2017-01-12
Last updated
2018-05-31

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03018522. Inclusion in this directory is not an endorsement.