Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery

Intracranial Pressure Increase Clinical Trial

Official title:

Ultrasonographic Evaluation of Intraoperative Optic Nerve Sheath Diameter Changes in Patients Undergoing Laparoscopic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209034
• Other study ID #: KÜ GOKAEK-2023/19.12
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pressure Increase
• Optic Nerve Sheath Diameter

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