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

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.

Study Overview

• Status: Completed
• Conditions: Robot-assisted Laparoscopic Prostatectomy Under General Anesthesia

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Associate Professor Department of Anesthesiology and Pain Medicine,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing robot-assisted laparoscopic prostatectomy; Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrasonographic measurement of optic nerve sheath diameter	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.	before anesthesia induction, 10 minutes after anesthesia induction, 30 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position, CO2 desufflation.

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: July 13, 2012
• First Posted (ESTIMATE): July 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 7, 2013
• Last Update Submitted That Met QC Criteria: August 5, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 4-2012-0287.