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

Sponsor
Akdeniz University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05692804
Collaborator
(none)
60
1
23.8
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 )

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Intraoperative Neuronal Damage in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy With S100beta, GFAP and NSE Biomarkers
Actual Study Start Date :
Mar 8, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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 )
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

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 )
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

Outcome Measures

Primary Outcome Measures

  1. brain damage [in 96 hours]

    Brain damge between the two groups will be compared

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Akdeniz University Hospital Antalya Turkey 07070

Sponsors and Collaborators

  • Akdeniz University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
İlker Onguc Aycan, PROFFESSOR,MD, Akdeniz University
ClinicalTrials.gov Identifier:
NCT05692804
Other Study ID Numbers:
  • Brain damage in RALRP
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by İlker Onguc Aycan, PROFFESSOR,MD, Akdeniz University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2023