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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05692804
Enrollment
59
Registered
2023-01-20
Start date
2022-03-08
Completion date
2024-09-17
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Damage, Postoperative, Surgery-Complications

Keywords

brain damage, postoperative, Robot-assisted laparoscopic radical prostatectomy (RALRP), GFAP, NSE, S100B

Brief summary

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.

Interventions

DIAGNOSTIC_TESTMini 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

Sponsors

Akdeniz University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Serum S100 Beta (S100β) ConcentrationPreoperative baseline and postoperative 1, 24, and 96 hoursSerum 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) ConcentrationPreoperative baseline and postoperative 1, 24, and 96 hoursSerum 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) ConcentrationPreoperative baseline and postoperative 1, 24, and 96 hoursSerum 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.

Secondary

MeasureTime frameDescription
Change From Baseline in Mini-Mental State Examination (MMSE) Total ScorePreoperative baseline and postoperative 6, 24, and 96 hoursCognitive 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.
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total ScorePreoperative baseline and postoperative 6, 24, and 96 hoursCognitive 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.
Number of Participants With an MMSE Total Score of 24 or LowerPostoperative 6, 24, and 96 hoursAt 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.
Number of Participants With a MoCA Total Score of 21 or LowerPostoperative 6, 24, and 96 hoursAt 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026