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

November 30, 2015 updated by: Young-Kug Kim, Asan Medical Center

Effects of Positive End-Expiratory Pressure Ventilation on Optic Nerve Sheath Diameter in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEEP group
Mechanical ventilation with PEEP 8 cmH2O
Other: PEEP
Mechanical ventilation with PEEP 8 cmH2O
No Intervention: No PEEP group
Mechanical ventilation with no PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optic nerve sheath diameter
Time Frame: intraoperative
intraoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate
Time Frame: intraoperative
intraoperative
Peak airway pressure
Time Frame: intraoperative
intraoperative
Arterial blood pressure
Time Frame: intraoperative
intraoperative
Arterial carbon dioxide tension
Time Frame: intraoperative
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AsanMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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