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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03031613

Enrollment

Registered

2017-01-25

Start date

2017-01-31

Completion date

2017-11-30

Last updated

2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

intraocular pressure, intracerebral pressure

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.

Interventions

PROCEDUREPEEP group

Application of 5cmH20 positive end expiratory pressure

PROCEDUREZEEP group

No application of positive end expiratory pressure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactDong Woo Han

hanesth@yuhs.ac02-2019-3529

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026