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

NCT ID: NCT05692804

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-08
• Study Completion Date: 2024-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group with Sevoflurane

The Sevoflurane used for maintenance of general anesthesia

Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )

Intervention Type: 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

The Propofol (IV) used for maintenance of general anesthesia

Mini Mental State Examination(MMSE),Montreal Cognitive Assessment ( MoCA),S100B ( protein S100 subunit beta) ,GFAP ( glial fibrillary acidic protein ),NSE ( neuron-specific enolase )

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

İlker Onguc Aycan

PROFFESSOR,MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Akdeniz University Hospital

Antalya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ilker O Aycan

Role: CONTACT

ilkeraycan@gmail.com

+905056702335

Bora Dinç

Role: CONTACT

drboradinc@gmail.com

+905323865600

Facility Contacts

Ilker O Aycan

Role: primary

ilkeraycan@gmail.com

+905056702335

References

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.

Reference Type: BACKGROUND

PMID: 24256501 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34709508 (View on PubMed)

Other Identifiers

Brain damage in RALRP

Identifier Type: -

Identifier Source: org_study_id