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Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy

NCT ID: NCT02516566

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-11-30

Brief Summary

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The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Detailed Description

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Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Conditions

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Other Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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PEEP group

Mechanical ventilation with PEEP 8 cmH2O

Group Type EXPERIMENTAL

PEEP

Intervention Type OTHER

Mechanical ventilation with PEEP 8 cmH2O

No PEEP group

Mechanical ventilation with no PEEP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PEEP

Mechanical ventilation with PEEP 8 cmH2O

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy

Exclusion Criteria

* Patients who have cerebrovascular disease or history of cerebrovascular disease
* Patients who are younger than 20 years
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Kug Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

References

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Chin JH, Kim WJ, Lee J, Han YA, Lim J, Hwang JH, Cho SS, Kim YK. Effect of Positive End-Expiratory Pressure on the Sonographic Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure during Robot-Assisted Laparoscopic Prostatectomy: A Randomized Controlled Trial. PLoS One. 2017 Jan 20;12(1):e0170369. doi: 10.1371/journal.pone.0170369. eCollection 2017.

Reference Type DERIVED
PMID: 28107408 (View on PubMed)

Other Identifiers

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AsanMC

Identifier Type: -

Identifier Source: org_study_id