Clinical trial NCT04910087: The Effect of Anesthesia Management on Optic Nerve Sheath Diameter in the Ercp Procedures
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Intracranial Pressure
Optic Nerve Sheath Diameter
Ketofol
Propofol
Keywords: Cholangiopancreatography, Endoscopic Retrograde
Intracranial Pressure
optic nerve sheath diameter
ketofol
propofol
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized double blinded study
Primary purpose: SCREENING

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: optic nerve sheath diameter change among 6 time period
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: ismail aytac
role: PRINCIPAL_INVESTIGATOR
References: