NCT03018522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 14, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

January 9, 2017

Last Update Submit

May 30, 2018

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Postoperative cognitive dysfunctionOTHER

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

Eligibility Criteria

Age50 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults between 50 and 90 years of age with robot assisted laparoscopic radical prostatectomy , were selected in the study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 27433840BACKGROUND

  • 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.

    PMID: 26417595BACKGROUND

  • 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.

    PMID: 25975969BACKGROUND

  • 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.

    PMID: 19575407BACKGROUND

  • 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.

    PMID: 33213866DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Nilgun Kavrut Ozturk, M.D.

    Antalya Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 12, 2017

Study Start

February 14, 2017

Primary Completion

November 24, 2017

Study Completion

February 14, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)