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NCT Number: NCT03214055

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year–79 year

Sex eligibility

Male

Study type

Observational

Primary location

Asan Medical center

Seoul, 05555, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Osmotic diuretic

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Optic nerve sheath diameter

    Time frame: 10 minutes after induction of anesthesia

    Optic nerve sheath diameter before mannitol administration

  4. Optic nerve sheath diameter

    Time frame: Intraoperative (during skin closure)

    Optic nerve sheath diameter after mannitol administration

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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