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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06209034
Other study ID # KÜ GOKAEK-2023/19.12
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 30, 2023
Est. completion date July 15, 2024

Study information

Verified date April 2024
Source Kocaeli University
Contact Sevim Cesur, MD
Phone +902623038248
Email svmcsr@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date July 15, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Other:
Optic nerve sheath measurement
ONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve.

Locations

Country Name City State
Turkey Kocaeli University Kocaeli
Turkey Sevim Cesur Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of optic nerve sheath diameter Ultrasound measurement of optic nerve sheath diameter during laparoscopic surgery During the operation
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