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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ismail aytac | Contact | +905056340369 | aytacismail1972@gmail.com | |
| ismail aytaç | Contact | aytacismail1972@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ismail aytac | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
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Prospective randomized double blinded study
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