- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06209034
Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery
Ultrasonographic Evaluation of Intraoperative Optic Nerve Sheath Diameter Changes in Patients Undergoing Laparoscopic Surgery
Laparoscopic surgery is a widely used alternative to open surgery; Advantages include reduced bleeding and pain intensity, shorter hospital stay, and improved cosmetic results.
Laparoscopic surgery involves the creation of a carbon dioxide (CO2) pneumoperitoneum to facilitate a clear surgical view, which can result in increased intracranial pressure (ICP).
Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment.Ultrasonographic assessment of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive measurement of intracranial pressure.
Study Overview
Status
Intervention / Treatment
Detailed Description
Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment. Previous studies have demonstrated that ultrasonographic measurement of ONSD correlates with the degree of ICP and can detect intracranial hypertension in a variety of clinical settings.
It was planned to measure the optic nerve sheath throughout the surgery with the help of a linear ultrasound probe.
Ultrasonographically, in each measurement, the optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes. ONSD will be measured bilaterally 3 mm behind the papilla. It will be evaluated by transverse measurement for each optic nerve.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kocaeli, Turkey (Türkiye)
- Kocaeli University
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Kocaeli, Turkey (Türkiye)
- Sevim Cesur
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Optic nerve sheath measurement
Optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes in each ultrasonographic measurement.
ONSD was measured bilaterally 3 mm posterior to the papilla.
Transverse measurements were made for each optic nerve.
|
ONSD was measured bilaterally 3 mm posterior to the papilla.
Transverse measurements were made for each optic nerve.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of optic nerve sheath diameter
Time Frame: During the operation
|
Ultrasound measurement of optic nerve sheath diameter during laparoscopic surgery
|
During the operation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sevim Cesur, Kocaeli University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KÜ GOKAEK-2023/19.12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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