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

Sponsor

Ankara City Hospital Bilkent (Other)

Overall Status

Recruiting

CT.gov ID

NCT04910087

Collaborator

(none)

100

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

15.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiopancreatography, Endoscopic Retrograde Intracranial Pressure Optic Nerve Sheath Diameter Ketofol Propofol	Diagnostic Test: Sonographic optic nerve sheath diameter measurement	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized double blinded studyProspective randomized double blinded study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Screening

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 15, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara City Hospital	Ankara		Turkey	06800

Sponsors and Collaborators

Ankara City Hospital Bilkent

Investigators

Principal Investigator: ismail aytac, Ankara City Hospital Bilkent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ismail aytaç, Anesthesiology Department, Ankara City Hospital Bilkent

ClinicalTrials.gov Identifier:

NCT04910087

Other Study ID Numbers:

E1/1786/2021

First Posted:

Jun 2, 2021

Last Update Posted:

Nov 9, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ismail aytaç, Anesthesiology Department, Ankara City Hospital Bilkent

Cholangiopancreatography, Endoscopic Retrograde

Intracranial Pressure

optic nerve sheath diameter

ketofol

propofol

Study Results

No Results Posted as of Nov 9, 2021