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

NCT03214055 | Completed

• 1 other identifier: 2017-0789
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  5 minutes after pneumoperitoneum and Trendelenburg position, 30 minutes after mannitol administration during pneumoperitoneum and Trendelenburg position

• Optic nerve sheath diameter

  10 minutes after induction of anesthesia

• Optic nerve sheath diameter

  Intraoperative (during skin closure)

Interventions

Mannitol DRUG

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.

Also known as: Osmotic diuretic

Eligibility Criteria

• Age: 20 Years - 79 Years
• Gender Eligibility Details: Only male included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical center

Seoul, 05555, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Mannitol; Diuretics, Osmotic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Young-Kug Kim, MD,PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: July 12, 2017
• Primary Completion: August 14, 2017
• Study Completion: August 20, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)