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

NCT05692804 | Completed

• 1 other identifier: Neuronal damage in RALRP
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Damage; Postoperative; Surgery-Complications

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Preoperative baseline and postoperative 1, 24, and 96 hours

Secondary Outcomes (4)

• Change From Baseline in Mini-Mental State Examination (MMSE) Total Score

  Preoperative baseline and postoperative 6, 24, and 96 hours

• Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score

  Preoperative baseline and postoperative 6, 24, and 96 hours

• Number of Participants With an MMSE Total Score of 24 or Lower

  Postoperative 6, 24, and 96 hours

• Number of Participants With a MoCA Total Score of 21 or Lower

  Postoperative 6, 24, and 96 hours

Study Arms (2)

Group with Sevoflurane

The Sevoflurane used for maintenance of general anesthesia

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

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 )

Interventions

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

Group with Propofol; Group with Sevoflurane

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 24256501 BACKGROUND

• 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.

  PMID: 34709508 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFFESSOR,MD

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 20, 2023
• Study Start: March 8, 2022
• Primary Completion: June 28, 2024
• Study Completion: September 17, 2024
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

TU (1)