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

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.

Study Overview

• Status: Recruiting
• Conditions: Propofol; Optic Nerve Sheath Diameter; Intracranial Pressure; Cholangiopancreatography, Endoscopic Retrograde; Ketofol
• Intervention / Treatment: Diagnostic test: Sonographic optic nerve sheath diameter measurement

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ismail aytaç; Email: aytacismail1972@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Recruiting
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group K: Ketofol; 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.	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.
Active Comparator: Group P: Propofol; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: İsmail Aytac, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 15, 2021

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: propofol; ketofol; Intracranial Pressure; Cholangiopancreatography, Endoscopic Retrograde; optic nerve sheath diameter
• Other Study ID Numbers: E1/1786/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No