Brain DamageNCT05692804

Evaluation of Neuronal Damage in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy With Biomarkers

An observational study of Brain Damage and Postoperative, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for: Brain Damage, Postoperative, Surgery-Complications
What is being tested?: Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )
Type of treatment: Injection or infusion
How many people: 59 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 8 Mar 2022to 17 Sep 2024
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Men only
Healthy volunteers accepted
Adult, Older adult

Study population: Patients aged 18-75 who were operated on under general anesthesia for RALRP surgery

Who may be able to join

All patients aged 18-75 who were operated on under general anesthesia for RALRP surgery and agreed to participate in the study will be included.

Who cannot join

Participants who did not accept the study, had active intracranial pathology and history of intracranial pathology will not be included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Akdeniz University Hospital
Antalya, 07070

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Intraoperative Neuronal Damage in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy With S100beta, GFAP and NSE Biomarkers

Robotic assisted laparoscopic surgery has become an alternative to open or laparoscopic technique in various surgical fields. Robot assisted laparoscopic surgery is preferred by surgeons and patients due to easy accessibility, lower blood loss and lower transfusion rates. However, robotic assisted laparoscopic surgery can cause significant changes in cardiovascular, respiratory, metabolic and cerebral physiology because it requires a deep trendy position. When long -lasting deep trendelenburg position is applied, the cerebral autoregulation is impaired. In the literature, the presence of cases with brain edema is shown.

In recent years, many biomarkers have been used in the evaluation of brain damage. S100 Calcium Binding Protein (S100β), N Ron specific enolase (NSE), Glial Fibrils are among the biomarkers used to show acidic protein (GFAP) brain damage. The S100β is specific and is mainly produced by astrocytes and enters the bloodstream after neuron damage. Glial fibrils is an acidic protein (GFAP), a protein encoded by the GFAP gene in humans, an intermediate filament protein produced in the central nervous system. Neuron specific enolase (NSE) is one of the enzymes that increase brain damage encoded by Enolase 2 (ENO2) gene.

Mini Mental State Examination and Montreal Cognitive Assessment will be performed to determine neurological changes developing in patients.

The purpose of this study; Robotic assisted laparoscopic surgery is to examine the brain damage that may develop in patients due to deep trendelenburg position in patients with the said biomarkers and to evaluate the anesthesia methods applied in these surgery in line with the study results.

Conditions: Brain Damage, Postoperative, Surgery-Complications
Being tested: Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )
Keywords: brain damage, postoperative, Robot-assisted laparoscopic radical prostatectomy (RALRP), GFAP, NSE, S100B
Medical subject headings: Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )Diagnostic test
MMSE and MoCA will be applied preoperative,postoperative first day and fourth day S100B,GFAP and NSE will be measured in blood tests preoperative,postoperative second hour,postoperative 24. hour and postoperative 96. hour

Study groups in NCT05692804
Study group	Role	What they receive
Group with Sevoflurane		The Sevoflurane used for maintenance of general anesthesia Receives: Diagnostic Test: Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )
Group with Propofol		The Propofol (IV) used for maintenance of general anesthesia Receives: Diagnostic Test: Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Serum S100 Beta (S100β) Concentration
Serum S100 beta (S100β) concentration was measured using a commercially available sandwich enzyme-linked immunosorbent assay and reported in ng/L. Change from the preoperative baseline concentration was evaluated at each postoperative measurement time point. A positive change indicates an increase and a negative change indicates a decrease relative to baseline.
Measured: Preoperative baseline and postoperative 1, 24, and 96 hours
Change From Baseline in Serum Neuron-Specific Enolase (NSE) Concentration
Serum neuron-specific enolase (NSE) concentration was measured using a commercially available sandwich enzyme-linked immunosorbent assay and reported in ng/mL. Change from the preoperative baseline concentration was evaluated at each postoperative measurement time point. A positive change indicates an increase and a negative change indicates a decrease relative to baseline.
Measured: Preoperative baseline and postoperative 1, 24, and 96 hours
Change From Baseline in Serum Glial Fibrillary Acidic Protein (GFAP) Concentration
Serum glial fibrillary acidic protein (GFAP) concentration was measured using a commercially available sandwich enzyme-linked immunosorbent assay and reported in ng/mL. Change from the preoperative baseline concentration was evaluated at each postoperative measurement time point. A positive change indicates an increase and a negative change indicates a decrease relative to baseline.
Measured: Preoperative baseline and postoperative 1, 24, and 96 hours

Secondary outcomes (4)

Change From Baseline in Mini-Mental State Examination (MMSE) Total Score
Cognitive performance was assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change from the preoperative baseline score was evaluated at each postoperative assessment. A negative change indicates a lower postoperative score relative to baseline.
Measured: Preoperative baseline and postoperative 6, 24, and 96 hours
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score
Cognitive performance was assessed using the Montreal Cognitive Assessment (MoCA). The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Change from the preoperative baseline score was evaluated at each postoperative assessment. A negative change indicates a lower postoperative score relative to baseline.
Measured: Preoperative baseline and postoperative 6, 24, and 96 hours
Number of Participants With an MMSE Total Score of 24 or Lower
At each postoperative assessment, participants with a Mini-Mental State Examination (MMSE) total score of 24 or lower were categorized as having threshold-based early cognitive performance decline. This threshold was used descriptively and was not intended to establish a formal diagnosis of postoperative neurocognitive disorder.
Measured: Postoperative 6, 24, and 96 hours
Number of Participants With a MoCA Total Score of 21 or Lower
At each postoperative assessment, participants with a Montreal Cognitive Assessment (MoCA) total score of 21 or lower were categorized as having threshold-based early cognitive performance decline. This threshold was used descriptively and was not intended to establish a formal diagnosis of postoperative neurocognitive disorder.
Measured: Postoperative 6, 24, and 96 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Mar 202217 Sep 2024

First posted20 Jan 2023
Study start8 Mar 2022
Primary completion28 Jun 2024
Study completion17 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Brain DamageStudies of the same condition, open and under way.
More trials run by Akdeniz UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05692804
Sponsor's protocol ID: Neuronal damage in RALRP
Status last verified: Jul 2026
First submitted: 12 Jan 2023
Last updated: 29 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Schramm P, Treiber AH, Berres M, Pestel G, Engelhard K, Werner C, Closhen D. Time course of cerebrovascular autoregulation during extreme Trendelenburg position for robotic-assisted prostatic surgery. Anaesthesia. 2014 Jan;69(1):58-63. doi: 10.1111/anae.12477. Epub 2013 Nov 20.
PubMed 24256501
Amoo M, Henry J, O'Halloran PJ, Brennan P, Husien MB, Campbell M, Caird J, Javadpour M, Curley GF. S100B, GFAP, UCH-L1 and NSE as predictors of abnormalities on CT imaging following mild traumatic brain injury: a systematic review and meta-analysis of diagnostic test accuracy. Neurosurg Rev. 2022 Apr;45(2):1171-1193. doi: 10.1007/s10143-021-01678-z. Epub 2021 Oct 28.
PubMed 34709508

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Intraoperative Neuronal Damage in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy With S100beta, GFAP and NSE Biomarkers
ClinicalTrials.gov ID: NCT05692804
Acronym / sponsor ID: Neuronal damage in RALRP
Conditions: Brain Damage, Postoperative, Surgery-Complications
Keywords: brain damage, postoperative, Robot-assisted laparoscopic radical prostatectomy (RALRP), GFAP, NSE, S100B
Study type: Observational
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Akdeniz UniversityUniversity, hospital or other
Study start: 8 Mar 2022 (actual)
Primary completion: 28 Jun 2024 (actual)
Study completion: 17 Sep 2024 (actual)
First posted: 20 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Mini Mental State Examination and Montreal Cognitive Assessment will be performed to determine neurological changes developing in patients.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Group with Sevoflurane	–	Diagnostic Test: Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )The Sevoflurane used for maintenance of general anesthesia
Group with Propofol	–	Diagnostic Test: Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )The Propofol (IV) used for maintenance of general anesthesia

Who may qualify

Ages: 18 to 70 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients aged 18-75 who were operated on under general anesthesia for RALRP surgery

Key inclusion criteria (1 listed)

All patients aged 18-75 who were operated on under general anesthesia for RALRP surgery and agreed to participate in the study will be included.

Key exclusion criteria (1 listed)

Participants who did not accept the study, had active intracranial pathology and history of intracranial pathology will not be included in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )MMSE and MoCA will be applied preoperative,postoperative first day and fourth day S100B,GFAP and NSE will be measured in blood tests preoperative,postoperative second hour,postoperative 24. hour and postoperative 96. hour	Diagnostic test	Group with Propofol, Group with Sevoflurane

Primary outcome

Change From Baseline in Serum S100 Beta (S100β) Concentration
Time frame: Preoperative baseline and postoperative 1, 24, and 96 hours
Serum S100 beta (S100β) concentration was measured using a commercially available sandwich enzyme-linked immunosorbent assay and reported in ng/L. Change from the preoperative baseline concentration was evaluated at each postoperative measurement time point. A positive change indicates an increase and a negative change indicates a decrease relative to baseline.
Change From Baseline in Serum Neuron-Specific Enolase (NSE) Concentration
Time frame: Preoperative baseline and postoperative 1, 24, and 96 hours
Serum neuron-specific enolase (NSE) concentration was measured using a commercially available sandwich enzyme-linked immunosorbent assay and reported in ng/mL. Change from the preoperative baseline concentration was evaluated at each postoperative measurement time point. A positive change indicates an increase and a negative change indicates a decrease relative to baseline.
Change From Baseline in Serum Glial Fibrillary Acidic Protein (GFAP) Concentration
Time frame: Preoperative baseline and postoperative 1, 24, and 96 hours
Serum glial fibrillary acidic protein (GFAP) concentration was measured using a commercially available sandwich enzyme-linked immunosorbent assay and reported in ng/mL. Change from the preoperative baseline concentration was evaluated at each postoperative measurement time point. A positive change indicates an increase and a negative change indicates a decrease relative to baseline.

4 secondary outcomes

Change From Baseline in Mini-Mental State Examination (MMSE) Total Score
Time frame: Preoperative baseline and postoperative 6, 24, and 96 hours
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score
Time frame: Preoperative baseline and postoperative 6, 24, and 96 hours
Number of Participants With an MMSE Total Score of 24 or Lower
Time frame: Postoperative 6, 24, and 96 hours
Number of Participants With a MoCA Total Score of 21 or Lower
Time frame: Postoperative 6, 24, and 96 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Background: PubMed 24256501Schramm P, Treiber AH, Berres M, Pestel G, Engelhard K, Werner C, Closhen D. Time course of cerebrovascular autoregulation during extreme Trendelenburg position for robotic-assisted prostatic surgery. Anaesthesia. 2014 Jan;69(1):58-63. doi: 10.1111/anae.12477. Epub 2013 Nov 20.
Background: PubMed 34709508Amoo M, Henry J, O'Halloran PJ, Brennan P, Husien MB, Campbell M, Caird J, Javadpour M, Curley GF. S100B, GFAP, UCH-L1 and NSE as predictors of abnormalities on CT imaging following mild traumatic brain injury: a systematic review and meta-analysis of diagnostic test accuracy. Neurosurg Rev. 2022 Apr;45(2):1171-1193. doi: 10.1007/s10143-021-01678-z. Epub 2021 Oct 28.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Damage and Postoperative, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Serum S100 Beta (S100β) Concentration (time frame: Preoperative baseline and postoperative 1, 24, and 96 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05692804, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.