Surgery-Complications Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | March 2024 |
| Est. primary completion date | February 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 70 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Akdeniz University Hospital | Antalya |
| Lead Sponsor | Collaborator |
|---|---|
| Akdeniz University |
Turkey,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | brain damage | Brain damge between the two groups will be compared | in 96 hours |