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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04910087

Enrollment

100

Registered

2021-06-02

Start date

2021-06-01

Completion date

2021-12-15

Last updated

2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cholangiopancreatography, Endoscopic Retrograde, Intracranial Pressure, optic nerve sheath diameter, ketofol, propofol

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).

Interventions

DIAGNOSTIC_TESTSonographic 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Prospective randomized double blinded study

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Contacts

Primary Contactismail aytac

aytacismail1972@gmail.com+905056340369

Backup Contactismail aytaç

aytacismail1972@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026