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The Effect of Pneumoperitoneum and Trendelenburg Position on Intracranial Pressure: Ultrasonographic Measurement of Optic Nerve Sheath Diameter

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ClinicalTrials.gov Identifier: NCT01641302
Recruitment Status : Completed
First Posted : July 16, 2012
Last Update Posted : August 7, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery.

Condition or disease
Robot-assisted Laparoscopic Prostatectomy Under General Anesthesia

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Study Start Date : June 2012
Primary Completion Date : August 2013
Study Completion Date : August 2013
Groups and Cohorts

Patients undergoing robot-assisted laparoscopic prostatectomy
Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia

Outcome Measures

Primary Outcome Measures :
  1. ultrasonographic measurement of optic nerve sheath diameter [ Time Frame: before anesthesia induction, 10 minutes after anesthesia induction, 30 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position, CO2 desufflation. ]
    A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements.

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia

Inclusion Criteria:

  • Adult patients (20-90 years of age) scheduled for undergoing robot-assisted laparoscopic prostatectomy undergoing general anesthesia

Exclusion Criteria:

  • Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641302

Korea, Republic of
Associate Professor Department of Anesthesiology and Pain Medicine,
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01641302     History of Changes
Other Study ID Numbers: 4-2012-0287.
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013