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

Ankara City Hospital

Status: Unknown

Conditions: Cholangiopancreatography, Endoscopic Retrograde; Optic Nerve Sheath Diameter; Propofol; Intracranial Pressure; Ketofol

Treatments: Diagnostic Test: Sonographic optic nerve sheath diameter measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04910087

E1/1786/2021

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Group K: Ketofol

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Sonographic optic nerve sheath diameter measurement

Group P: Propofol

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Sonographic optic nerve sheath diameter measurement