Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage

Study Overview
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Brief Summary
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Magnetic Endoscope Imaging (MEI) is an optional tool which can be switched on at the beginning of colonoscopy. MEI works by creating an electromagnetic field of very low intensity. By that the position of the endoscope can be displayed virtually on a monitor. The use of MEI has been shown to reduce the formation of loops and to ease the removal of existing loops during the investigation. Furthermore, as loops favour the occurrence of pain when the scope is moved forward, patients who underwent colonoscopy with MEI reported less pain at the end of the procedure. Sedation is used widely during colonoscopy for it has improved the tolerability of the investigation. Most of the patients demand for sedation. In Germany Propofol is recommended as the first-line sedative when endoscopy it is performed in an outpatient setting. The use of Propofol involves the danger of respiratory complications. One reason for the application of Propofol doses is the occurrence of pain during the investigation. We hypothesized that if MEI is used and if loops can be avoided sufficiently lower Propofol doses would be needed. We therefore planned this prospective controlled trial.

Conditions
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Failed Conscious Sedation During Procedure

Intervention / Treatment
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* Device: Magnetic Endoscope Imaging (Scope Guide)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: medical indication for colonoscopy age >18 years written consent given by patient investigation under sedation with propofol Exclusion Criteria: application of any other sedative than propofol age < 18 years pregnant women patients denying written consent ASA class IV, V and VI indication for colonoscopy: emergency (e.g. severe rectal bleeding) allergy to propofol pre-existing hypotension, bradycardia or hypoxemia history of sedation accidents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Controll Group<br>Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. The Magnetic Endoscope Imaging (Scope Guide) function WILL NOT BE USED during the investigation. | |
| Active Comparator: Intervention<br>Patients from the control group will be examined using a CF-HQ 190 EVIS Exera III Advanced Diagnostic Video Colonoscope. The Magnetic Endoscope Imaging (Scope Guide) function WILL BE USED during the investigation. | Device: Magnetic Endoscope Imaging (Scope Guide)<br> <br> * Other names: brand name: Scope guide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Propofol dose | At the end of colonoscopy total dose of Propofol applicated will be assessed. | up to one day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Oxygen saturation will be measured for the duration of colonoscopy/hospital stay. | up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day) | 
| Adenoma detection rate |  | up to one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Colonoscopy, Propofol, Scope guide