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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214055
• Other study ID #: 2017-0789
• Status: Completed
• Phase: N/A
• First received: July 7, 2017
• Last updated: August 24, 2017
• Start date: July 12, 2017
• Est. completion date: August 20, 2017

Study information

• Verified date: August 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 20, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• Mannitol
The mannitol has been administered routinely to prevent renal dysfunction in patients undergoing robot-assisted laparoscopic radical prostatectomy. Participants will receive the mannitol as part of routine medical care, and we will evaluate the change in optic nerve sheath diameters before and after mannitol administration.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in optic nerve sheath diameters	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	Change in optic nerve sheath diameters	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
Secondary	Change in optic nerve sheath diameters	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
Secondary	Optic nerve sheath diameter	Optic nerve sheath diameter before mannitol administration	10 minutes after induction of anesthesia
Secondary	Optic nerve sheath diameter	Optic nerve sheath diameter after mannitol administration	Intraoperative (during skin closure)