Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery

NCT ID: NCT06209034

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-30
• Study Completion Date: 2024-09-15

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.

Conditions

Optic Nerve Sheath Diameter; Intracranial Pressure Increase

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Optic nerve sheath measurement

Intervention Type: OTHER

ONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve.

Interventions

Optic nerve sheath measurement

ONSD was measured bilaterally 3 mm posterior to the papilla. Transverse measurements were made for each optic nerve.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Sevim Cesur

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevim Cesur

Role: STUDY_DIRECTOR

Kocaeli University

Locations

Kocaeli University

Kocaeli, , Turkey (Türkiye)

Sevim Cesur

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KÜ GOKAEK-2023/19.12

Identifier Type: -

Identifier Source: org_study_id