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Completed

NCT Number: NCT01840267

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

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.

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Key information

Age range

Up to 9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ultrasonographic measurement of optic nerve sheath diameter

Device

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.

Primary outcomes

  1. ultrasonographic measurement of optic nerve sheath diameter

    Time frame: change of ultrasonographic measurement of optic nerve sheath in 10 minutes after anesthesia induction, 10 minutes after pneumoperitoneum, and 10 minutes after 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2013
Registry last updated
Sep 27, 2013

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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