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

Propofol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910087
• Other study ID #: E1/1786/2021
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Intracranial Pressure
• Optic Nerve Sheath Diameter
• Propofol

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