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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01641302
First received: June 28, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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
Robot-assisted Laparoscopic Prostatectomy Under General Anesthesia

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: June 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing robot-assisted laparoscopic prostatectomy
Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01641302

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01641302     History of Changes
Other Study ID Numbers: 4-2012-0287.
Study First Received: June 28, 2012
Last Updated: August 5, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on August 21, 2014