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

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03214055
Collaborator
(none)
39
Enrollment
1
Location
1.3
Actual Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
39 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Radical Prostatectomy: a Prospective Observational Study
Actual Study Start Date :
Jul 12, 2017
Actual Primary Completion Date :
Aug 14, 2017
Actual Study Completion Date :
Aug 20, 2017

Outcome Measures

Primary Outcome Measures

  1. Change in optic nerve sheath diameters [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

Secondary Outcome Measures

  1. Change in optic nerve sheath diameters [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

  2. Change in optic nerve sheath diameters [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

  3. Optic nerve sheath diameter [10 minutes after induction of anesthesia]

    Optic nerve sheath diameter before mannitol administration

  4. Optic nerve sheath diameter [Intraoperative (during skin closure)]

    Optic nerve sheath diameter after mannitol administration

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 79 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical center Seoul Korea, Republic of 05555

Sponsors and Collaborators

  • Asan Medical Center

Investigators

  • Principal Investigator: Young-Kug Kim, MD,PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Young-Kug Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT03214055
Other Study ID Numbers:
  • 2017-0789
First Posted:
Jul 11, 2017
Last Update Posted:
Aug 25, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms
Mannitol
Diuretics

Study Results

No Results Posted as of Aug 25, 2017