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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04718558
Other study ID # 2020/271
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date July 1, 2021

Study information

Verified date November 2021
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in optic nerve sheath diameter Change in optic nerve sheath diameter as assessed by rapid ultrasound scan before general anesthesia, after intubation, 1 minute, 10 minutes, 20 minutes, 40 minutes, 60 minutes after mouth gag is inserted and after mouth gape is removed After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Secondary Change in heart rate Change in heart rate by using electrocardiogram on the anesthesia workstation After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Secondary Change in End tidal CO2 Change in End tidal CO2 by using capnography on the anesthesia workstation After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
Secondary Change in Peak inspiratory pressure (PIP) workstation Change in Peak inspiratory pressure (PIP) by using monitoring on the anesthesia After general anesthesia induction, after endotracheal intubation, after mouth gag insertion (primary timepoint), 20 minutes, 40 minutes, 60 minutes after mouth gag insertion
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