NCT06209034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

January 6, 2024

Last Update Submit

March 16, 2026

Conditions

Optic Nerve Sheath DiameterIntracranial Pressure Increase

Keywords

UltrasonographyOptic nerve sheath diameterLaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Evaluation of optic nerve sheath diameter

    Ultrasound measurement of optic nerve sheath diameter during laparoscopic surgery

    During the operation

Study Arms (1)

Optic nerve sheath measurement

OTHER

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.

Other: Optic nerve sheath measurement

Interventions

Optic nerve sheath measurementOTHER

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

Optic nerve sheath measurement

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged patients
  • American Society of Anesthesiologists Classification (ASA) I-II-III patients
  • Patients undergoing laparoscopic surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Sevim Cesur

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Sevim Cesur

    Kocaeli University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Single(Participant)
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 6, 2024

First Posted

January 17, 2024

Study Start

December 30, 2023

Primary Completion

July 31, 2024

Study Completion

September 15, 2024

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

TU(2)