The Effect of Pneumoperitoneum on Intracranial Pressure in Pediatric Laparoscopic Surgery: Ultrasonographic Measurement of Optic Nerve Sheath Diameter

Intracranial Pressure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840267
• Other study ID #: 4-2013-0090
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: September 25, 2013
• Start date: April 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The pneumoperitoneum during laparoscopic surgery in pediatrics has 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 aims to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery in pediatric patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 9 Years

Eligibility

Inclusion Criteria:

1. pediatric patients (under 9 yrs) scheduled for undergoing laparoscopic surgery under general anesthesia

Exclusion Criteria:

1. Patients with previous history of neurologic disease or neurosurgery, ocular disease or ocular surgery

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Intracranial Pressure
• Pneumoperitoneum

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change of ultrasonographic measurement of optic nerve sheath in 10 minutes after anesthesia induction, 10 minutes after pneumoperitoneum, and 10 minutes after CO2 desufflation.	No