Patients requiring radical prostatectomy who are positioned in Trendelenburg position for several hours due to surgery.
Conditions
Interventions
Group 1: Patients undergoing radical prostatectomy and operated on with the daVinci surgical robot in the Trendelenburg position.
Group 2: Patients undergoing radical prostatectomy and operated on wit
Sponsors
LMU Klinikum, Klinik für Anästhesiologie
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: -Patient is able to give consent and available written informed consent. -planned radical prostatectomy
Exclusion criteria
Exclusion criteria: - Subjects who are not capable of giving consent - missing signed informed consent - Known neurological disease with or without elevated intracranial pressure. - Known underlying psychiatric disease with or without permanent medication - Eye disease (e.g. glaucoma) - Severe lung disease - Immunosuppressive medication - Participation in another research project or clinical trial that conflicts with this study - Known severe autoimmune disease resulting in classification of ASA Group III or higher - Known alcohol, drug or medication abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of neurofilament light chain (NFL) in blood perioperatively (preoperative, surgery day of surgery, postoperative day 1, day 3 and on the day before discharge). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Measurement of other markers of endothelial function and blood-brain barrier (matrix metalloproteinase-2/-9, zonulin, S100B, NSE, GFAP, tau and amyloid proteins Aß40, and Aß42, glycocalyx components: Hyaluronan, syndecan-1 and heparan sulphate). - Estimation of intracranial pressure using focused sonographic survey of optic nerve sheath diameter (ONSD). - Cognitive testing (Memory test, clock test, MMSE) - Delirium assessment (Nursing Delirium Screening Scale (Nu-DESC)) - Survey of classic physiological stress parameters (cortisol in saliva, catecholamines [plasma/urine]), current stress test (CST) - Headache assessment by questionnaire - Determination of systemic inflammation markers (leukocytes, plasma cytokines, adhesion molecules, cellular activation markers) - Transcriptome analysis (mRNA) and Western blot (whole blood) to analyse signalling cascades at RNA and protein level - MRI correlation of effects (optional, in selected patients) - Survey of parameters from routine anaesthesia: end-tidal CO2, intraoperative gas exchange in Trendelenburg by blood gas analysis, type of anaesthesia, use of anaesthetic gas (yes/no), blood loss, mean arterial blood pressure (MAP), incision-suture time/anaesthesia time. | — |
Countries
Germany
Contacts
Public ContactJudith-Irina Buchheim
LMU Klinikum, Klinik für Anästhesiologie
Outcome results
None listed