Clinical Trials Directory

Trials / Unknown

UnknownNCT04910087

The Effect of Anesthesia Management on Optic Nerve Sheath Diameter in the Ercp Procedures

Comparison of the Effect od Ketofol and Propofol on Intracranial Pressure Evaluated by Sonographic Optic Nerve Sheath Diameter Measurements in the Endoscopic Retrograde Cholangiopancreatography Procedures

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Ankara City Hospital Bilkent · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Detailed 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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSonographic optic nerve sheath diameter measurementWith 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.

Timeline

Start date
2021-06-01
Primary completion
2021-12-01
Completion
2021-12-15
First posted
2021-06-02
Last updated
2021-11-09

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04910087. Inclusion in this directory is not an endorsement.