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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04910087
Other study ID # E1/1786/2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 15, 2021

Study information

Verified date November 2021
Source Ankara City Hospital Bilkent
Contact ismail aytac
Phone +905056340369
Email aytacismail1972@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim: To compare the effect of procedural anesthesia management with ketofol and propofol on the sonographic optic nerve sheath diameter in the endoscopic retrograde cholangiopancreatography (ERCP) procedures.


Description:

Adequate visualization of the gastrointestinal mucosa during endoscopic retrograde cholangiopancreatography (ERCP) requires distention of the intestinal lumen by gas insufflation. High intraluminal pressures can increase intraabdominal pressure, leading to an increase in intracranial pressure. Ultrasonographic measurement of the optic nerve sheath diameter is a simple, non-invasive, and reliable technique for assessing intracranial pressure. Propofol, a sedative-hypnotic agent with rapid onset and short duration of action, is often used.Theoretically, the combination of ketamine and propofol may maintain sedation efficacy while reducing cardiovascular side effects through dose reduction and due to its synergistic effects. 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 15, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients undergoing ERCP procedure - ASA score of I, II, and III Exclusion Criteria: - chronic lung disease - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary optic nerve sheath diameter change among 6 time period Baseline, immediately after anesthesia induction, immediately after gas insufflation, 10th minute of the ERCP procedure,20th minute of the ERCP procedure,immediately after completion of the ERCP procedure
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