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

Not Applicable

• Conditions: Intracranial Pressure; Cholangiopancreatography, Endoscopic Retrograde; Optic Nerve Sheath Diameter; Propofol; Ketofol
• Interventions: Diagnostic Test: Sonographic optic nerve sheath diameter measurement

• Registration Number: NCT04910087
• Lead Sponsor: Ankara City Hospital Bilkent

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).

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-28
• Study Start: 2021-06-01
• Study First Posted: 2021-06-02
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-07
• Last Update Posted: 2021-11-09
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group K: Ketofol	Sonographic optic nerve sheath diameter measurement	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.
Group P: Propofol	Sonographic optic nerve sheath diameter measurement	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey