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

NCT04910087 | Unknown

• 1 other identifier: E1/1786/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group K: Ketofol

ACTIVE COMPARATOR

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

Group P: Propofol

ACTIVE COMPARATOR

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

Interventions

Sonographic optic nerve sheath diameter measurement DIAGNOSTIC_TEST

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.

Group K: Ketofol; Group P: Propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing ERCP procedure
• ASA score of I, II, and III

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Study Officials

• ismail aytac

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ismail aytac

CONTACT

+905056340369; aytacismail1972@gmail.com

ismail aytaç

CONTACT

aytacismail1972@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Department

Model Details: Prospective randomized double blinded study

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 2, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 15, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)