Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robotic Prostatectomy

August 24, 2017 updated by: Young-Kug Kim, Asan Medical Center

Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy: a Prospective Observational Study

We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial pressure before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mannitol has been frequently used for renal protection during surgery. Optic nerve sheath diameter is used to evaluate intracranial pressure noninvasively. Robot-assisted laparoscopic radical prostatectomy can induce an increase in optic nerve sheath diameter due to Trendelenburg position and carbon dioxide insufflation. We therefore aim to evaluate the change in optic nerve sheath diameters before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Prostate cancer patients who undergo Robot-assisted laparoscopic radical prostatectomy.

Description

Inclusion Criteria:

  • prostate cancer patients undergoing robot assisted laparoscopic radical prostatectomy.
  • 20 year old or above, 79 year old or below.
  • agreed to participate this study.

Exclusion Criteria:

  • history of cerebrovascular accident.
  • history of congestive heart failure.
  • history of pulmonary edema.
  • history of anaphylaxis to mannitol.
  • conversion to open prostatectomy.
  • combined with other operation.
  • inability to measure optic nerve sheath diameter.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in optic nerve sheath diameters
Time Frame: 5 minutes after pneumoperitoneum and Trendelenburg position, 90 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Change in optic nerve sheath diameters before and after mannitol administration
5 minutes after pneumoperitoneum and Trendelenburg position, 90 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in optic nerve sheath diameters
Time Frame: 5 minutes after pneumoperitoneum and Trendelenburg position, 60 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Change in optic nerve sheath diameters before and after mannitol administration
5 minutes after pneumoperitoneum and Trendelenburg position, 60 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Change in optic nerve sheath diameters
Time Frame: 5 minutes after pneumoperitoneum and Trendelenburg position, 30 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Change in optic nerve sheath diameters before and after mannitol administration
5 minutes after pneumoperitoneum and Trendelenburg position, 30 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position
Optic nerve sheath diameter
Time Frame: 10 minutes after induction of anesthesia
Optic nerve sheath diameter before mannitol administration
10 minutes after induction of anesthesia
Optic nerve sheath diameter
Time Frame: Intraoperative (during skin closure)
Optic nerve sheath diameter after mannitol administration
Intraoperative (during skin closure)

Collaborators and Investigators

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

Sponsor

Asan Medical Center

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 (Actual)

July 12, 2017

Primary Completion (Actual)

August 14, 2017

Study Completion (Actual)

August 20, 2017

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Locations

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