S100B Protein and Postoperative Cognitive Dysfunction

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018522
• Other study ID #: AntalyaTRH14
• Status: Completed
• Start date: February 14, 2017
• Est. completion date: February 14, 2018

Study information

• Verified date: May 2018
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 14, 2018
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Intervention

Other:
• Postoperative 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

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score in Neuropsychological Tests	This assessment will be applied before surgery, and 7 days and 3 months after surgery.	Change from neuropsychological test scores at 3 months.