S100B Protein and Postoperative Cognitive Dysfunction

May 30, 2018 updated by: Antalya Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07100
        • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from neuropsychological test scores at 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Study Director: Nilgun Kavrut Ozturk, M.D., Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2017

Primary Completion (Actual)

November 24, 2017

Study Completion (Actual)

February 14, 2018

Study Registration Dates

First Submitted

January 9, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AntalyaTRH14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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