Evaluation of Intraoperative Neuronal Damage in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy With S100beta, GFAP and NSE Biomarkers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Akdeniz University
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Serum S100 Beta (S100β) Concentration
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
Group with Sevoflurane
The Sevoflurane used for maintenance of general anesthesia
Intervention: 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)
Group with Propofol
The Propofol (IV) used for maintenance of general anesthesia
Intervention: 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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
İlker Onguc Aycan
PROFFESSOR,MD
Akdeniz University