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Completed

NCT Number: NCT03018522

S100B Protein and Postoperative Cognitive Dysfunction

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.

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Key information

Age range

50 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative cognitive dysfunction

Other

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

Primary outcomes

  1. Score in Neuropsychological Tests

    Time frame: Change from neuropsychological test scores at 3 months.

    This assessment will be applied before surgery, and 7 days and 3 months after surgery.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 12, 2017
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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