The Effect of Anesthesia Management on Optic Nerve Sheath Diameter in the Ercp Procedures
NCT ID: NCT04910087
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-06-01
2021-12-15
Brief Summary
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Detailed Description
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The aim of this study is to demonstrate whether our anesthesia management has an effect on ICP change by measurement of optic nerve sheath diameter, predicting that insufflation performed for imaging during the ERCP procedure increase intraabdominal pressure, and frequently observed situations such as insufficient sedation, prone position, coughing and Valsalva during the procedure increase intracranial pressure (ICP).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
QUADRUPLE
Study Groups
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Group K: Ketofol
A ketofol mixture of 15 cc propofol 2%, 2 cc ketamine 50 mg/ml, and 13 cc serum saline will be prepared in a 50 cc non-transparent syringe and delivered to the patient intravenously through perfuser device. (at a ratio of 100 mg ketamine/300 mg propofol) After the loading dose is administered at 1 mg/kg IV in 5 minutes based on propofol, 0.5 cc/kg/hour ketofol infusion will be initiated.
If patients cannot tolerate the ERCP procedure or have a BIS value \>85 or FPS (Faces Pain Scale)\> 3, 0.25 mg/kg propofol will be administered as a separate IV push.
Sonographic optic nerve sheath diameter measurement
With the linear ultrasound probe operating at 11 MHz in B mode, it will be measured in 2 planes, 3.0 mm behind the optic disc, the transverse plane where the probe is placed horizontally and the sagittal plane where the probe is placed vertically. Then, the average of these measurements will be recorded for both eyes every 10 minutes.
Group P: Propofol
A propofol mixture of 15 cc propofol 2% and 15 cc serum saline will be prepared in a 50 cc non-transparent syringe and delivered to the patient intravenously through the perfuser device.
After the loading dose is administered at 1 mg/kg IV propofol in 5 minutes ,0.5 cc/kg/hour propofol infusion will be initiated.
If patients cannot tolerate the ERCP procedure or have a BIS value \>85 or FPS (Faces Pain Scale)\> 3, 0.25 mg/kg propofol will be administered as a separate IV push
Sonographic optic nerve sheath diameter measurement
With the linear ultrasound probe operating at 11 MHz in B mode, it will be measured in 2 planes, 3.0 mm behind the optic disc, the transverse plane where the probe is placed horizontally and the sagittal plane where the probe is placed vertically. Then, the average of these measurements will be recorded for both eyes every 10 minutes.
Interventions
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Sonographic optic nerve sheath diameter measurement
With the linear ultrasound probe operating at 11 MHz in B mode, it will be measured in 2 planes, 3.0 mm behind the optic disc, the transverse plane where the probe is placed horizontally and the sagittal plane where the probe is placed vertically. Then, the average of these measurements will be recorded for both eyes every 10 minutes.
Eligibility Criteria
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Inclusion Criteria
* ASA score of I, II, and III
Exclusion Criteria
* renal or hepatic failure
* uncontrolled comorbidities (diabetes mellitus, hypertension, etc.)
* central nervous system disease
* pregnancy
* undergoing optic nerve surgery
* glaucoma or increased intraocular pressure, and retinal detachment
18 Years
80 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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ismail aytaç
Anesthesiology Department
Principal Investigators
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ismail aytac
Role: PRINCIPAL_INVESTIGATOR
Ankara City Hospital Bilkent
Locations
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Ankara City Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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İsmail Aytac
Role: primary
Other Identifiers
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E1/1786/2021
Identifier Type: -
Identifier Source: org_study_id