Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery

Not Applicable

Recruiting

• Conditions: Optic Nerve Sheath Diameter; Intracranial Pressure Increase
• Interventions: Other: Optic nerve sheath measurement

• Registration Number: NCT06209034
• Lead Sponsor: Kocaeli University

Brief 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.

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 Timeline

• Study Start: 2023-12-30
• Study First Submitted: 2024-01-06
• Study First Submitted QC: 2024-01-06
• Study First Posted: 2024-01-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-29
• Primary Completion: 2024-05-31
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optic nerve sheath measurement	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of optic nerve sheath diameter	During the operation	Ultrasound measurement of optic nerve sheath diameter during laparoscopic surgery

Trial Locations

Locations (2)

Kocaeli University; 🇹🇷 Kocaeli, Turkey

Sevim Cesur; 🇹🇷 Kocaeli, Turkey