CompletedNot Applicable

Optic Nerve Sheath Diameter Measurement in Cleft Palate Repair

Turkey (Türkiye)30 participantsStarted 2020-10-01

Plain-language summary

The aim of this study is to evaluate the effect of the Boyle-Davis mouth opener, which is routinely used in cleft palate surgery, on intracranial pressure by USG-guided optic nerve sheath diameter measurement, which is a non-invasive method with proven effectiveness and reliability in recent years.

Who can participate

Age range3 Months – 24 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged between 3-24 month and with an ASA physical status I-II and undergoing cleft palate surgery will be included to the study. Exclusion Criteria: * Exclusion criteria will be preexisting acute or chronic eye disease, * History of eye surgery, use of drugs known to influence intraocular pressure (IOP) (ß blockers, Ca channel blockers, statins and nitrates) * Conditions that may cause known intracranial pressure changes (cerebrovascular event, bleeding, an intracranial tumor, etc.) * patients' parental refusal

What they're measuring

change in optic nerve sheath diameter

Timeframe: After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion

Trial details

NCT IDNCT04718558

SponsorKaradeniz Technical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-05-15

View on ClinicalTrials.gov More Cleft Palate trials