Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage

Not Applicable

Completed

• Conditions: Failed Conscious Sedation During Procedure
• Interventions: Device: Magnetic Endoscope Imaging (Scope Guide)

• Registration Number: NCT02121704
• Lead Sponsor: Technical University of Munich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Study Start: 2014-05
• Primary Completion: 2015-08
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Magnetic Endoscope Imaging (Scope Guide)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 München, Deutschland, Germany