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

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ClinicalTrials.gov Identifier: NCT01840267
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : September 27, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease Intervention/treatment
Intracranial Pressure Device: ultrasonographic measurement of optic nerve sheath diameter

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Study Type : Observational
Actual Enrollment : 25 participants
Time Perspective: Prospective
Study Start Date : April 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Group/Cohort Intervention/treatment
laparoscopic surgery under general anesthesia
pediatric patients undergoing laparoscopic surgery under general anesthesia
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.




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric patients undergoing laparoscopic surgery under general anesthesia
Criteria

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


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): NCT01840267


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01840267     History of Changes
Other Study ID Numbers: 4-2013-0090
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: September 27, 2013
Last Verified: September 2013
Keywords provided by Yonsei University:
pneumoperitoneum
pediatric laparoscopy
optic nerve sheath diameter
intracranial pressure
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases