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NCT06403592 Clinical Trial

The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter

Intracranial Pressure Increase Clinical Trial

— ONSD laryngeal  

Official title:
The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06403592
Other study ID # ONSD laryngeal
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 25, 2024
Est. completion date March 25, 2026

Study information
Verified date May 2024
Source Erasmus Medical Center
Contact Dr. Maissan
Phone +31628552301
Email i.maissan@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational trial is to study the effect of a laryngeal airway mask on the optic nerve sheath diameter, as a surrogate for intracranial pressure. The optic nerve sheath diameter of participants will be measured under general anesthesia, before, during and after insertion of a laryngeal airway mask.

Recruitment information / eligibility
Status Recruiting
Enrollment 230
Est. completion date March 25, 2026
Est. primary completion date March 25, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - In order to be eligible to participate in this study, a subject must meet all of the following criteria: aged 18 years or older, ASA I or ASA II, scheduled for elective surgery under general anesthesia, with a planned duration of > 30 minutes, that can be routinely performed with a LMA. Exclusion Criteria: - Scheduled for head or neck surgery - Scheduled for neurosurgery - Scheduled for laparoscopic or thorascoscopic procedures - Scheduled for procedures that require Trendelenburg or anti-Trendelenburg positioning - Neurological disorders - Glaucoma - History of bilateral eye related trauma - Intellectual disability

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• optic nerve sheath diamater
Measurement of optic nerve sheath diameter

Locations
Country Name City State
Netherlands Erasmus Medisch Centrum Rotterdam

Sponsors (1)
Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of insertion of a laryngeal airway mask on optic nerve sheath diameter During surgery
Secondary Effect of laryngeal ariway mask after insertion on optic nerve sheath diameter During surgery
Secondary Effect of layngeal airway mask on optic nerve sheath diameter interna vs optic nerve sheath diameter externa During surgery
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