Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy

Study Overview
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Brief Summary
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To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted laparoscopic radical prostatectomy (RALRP)

Detailed Description
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Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP. This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing RALRP.

Official Title
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Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: PEEP group
* Procedure: ZEEP group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing robotic-assisted laparoscopic radical prostatectomy Exclusion Criteria: History of opthalmic disease or surgery History of brain disease or surgery Known ICP elevation Known IOP elevation Presence of lung bullae on chest x-ray History of pneumothorax
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEP group<br>Application of 5 cmH2O PEEP during mechanical ventilation | Procedure: PEEP group<br>* Application of 5cmH20 positive end expiratory pressure<br>|
| Active Comparator: ZEEP group<br>No application of PEEP during mechanical ventilation | Procedure: ZEEP group<br>* No application of positive end expiratory pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP | IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA® | Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min | 
| ICP | ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound | Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular pressure, intracerebral pressure