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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01840267
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 6.2

Study Details

Study Description

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	Phase
Intracranial Pressure	Device: ultrasonographic measurement of optic nerve sheath diameter

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Time Perspective: Prospective
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. ultrasonographic measurement of optic nerve sheath diameter [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01840267
• Other Study ID Numbers: 4-2013-0090
• First Posted: Apr 25, 2013
• Last Update Posted: Sep 27, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Yonsei University: pneumoperitoneum; pediatric laparoscopy; optic nerve sheath diameter; intracranial pressure
• Additional relevant MeSH terms: Pneumoperitoneum

Study Results

No Results Posted as of Sep 27, 2013