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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03214055
• Lead Sponsor: Asan Medical Center

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.

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 Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Study Start: 2017-07-12
• Status Verified: 2017-08
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-20
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Optic nerve sheath diameter	Intraoperative (during skin closure)	Optic nerve sheath diameter after mannitol administration

Trial Locations

Locations (1)

Asan Medical center; 🇰🇷 Seoul, Korea, Republic of