Measuring optic nerve sheath diameter during laparoscopic surgery
Ultrasonographic Evaluation of Intraoperative Optic Nerve Sheath Diameter Changes in Patients Undergoing Laparoscopic Surgery
This study is testing how laparoscopic surgery affects the size of the optic nerve sheath to see if it can indicate changes in pressure inside the skull.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kocaeli University Academic / other |
| Locations | 2 sites (Kocaeli and 1 other locations) |
| Trial ID | NCT06209034 on ClinicalTrials.gov |
What this trial studies
This study investigates the changes in optic nerve sheath diameter (ONSD) during laparoscopic surgery using ultrasonography. It aims to assess the relationship between laparoscopic procedures and potential increases in intracranial pressure (ICP) by measuring ONSD non-invasively. The measurements will be taken bilaterally at a specific point behind the optic nerve entry into the globe throughout the surgical process. This approach seeks to provide real-time data on ICP changes during surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18-75 who are classified as ASA I-III and are scheduled for laparoscopic surgery.
Not a fit: Patients with ASA IV-V classifications, known ophthalmic diseases, or a history of neurological disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of intracranial pressure dynamics during laparoscopic surgery, potentially improving patient safety and outcomes.
How similar studies have performed: Previous studies have shown that ultrasonographic measurement of ONSD is a reliable method for assessing ICP, indicating that this approach has been validated in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-75 aged patients * American Society of Anesthesiologists Classification (ASA) I-II-III patients * Patients undergoing laparoscopic surgery Exclusion Criteria: * American Society of Anesthesiologists Classification (ASA) IV-V patients * Those with known ophthalmic disease * Those with a history of ophthalmic surgery * Those with any known neurological disorder * History of intracranial hypertension * Patients who will undergo open abdominal surgery
Where this trial is running
Kocaeli and 1 other locations
- Kocaeli University — Kocaeli, Turkey (Recruiting)
- Sevim Cesur — Kocaeli, Turkey (Active_not_recruiting)
Study contacts
- Study coordinator: Sevim Cesur, MD
- Email: svmcsr@gmail.com
- Phone: +902623038248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.