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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Procedure: ZEEP group; Procedure: PEEP group

• Registration Number: NCT03031613
• Lead Sponsor: Gangnam Severance Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-24
• Last Update Submitted: 2017-01-24
• Study First Posted: 2017-01-25
• Last Update Posted: 2017-01-25
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZEEP group	ZEEP group	No application of PEEP during mechanical ventilation
PEEP group	PEEP group	Application of 5 cmH2O PEEP during mechanical ventilation

Primary Outcome Measures

Name	Time	Method
IOP	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	IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®
ICP	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 is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound

Trial Locations

Locations (1)

Yonsei University Medical College Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of