The Effect of Pneumoperitoneum on Intracranial Pressure in Pediatric Laparoscopic Surgery: Ultrasonographic Measurement of Optic Nerve Sheath Diameter
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedSeptember 27, 2013
September 1, 2013
4 months
April 17, 2013
September 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
laparoscopic surgery under general anesthesia
pediatric patients undergoing laparoscopic surgery under general anesthesia
Interventions
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.
Eligibility Criteria
pediatric patients undergoing laparoscopic surgery under general anesthesia
You may qualify if:
- \. pediatric patients (under 9 yrs) scheduled for undergoing laparoscopic surgery under general anesthesia
You may not qualify if:
- \. Patients with previous history of neurologic disease or neurosurgery, ocular disease or ocular surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
April 25, 2013
Study Start
April 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
September 27, 2013
Record last verified: 2013-09