Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage (MEXICO)

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.

Study Overview

• Status: Completed
• Conditions: Failed Conscious Sedation During Procedure
• Intervention / Treatment: Device: Magnetic Endoscope Imaging (Scope Guide)

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Deutschland
    • München, Deutschland, Germany, 81675
      • II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controll Group; 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; 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); Other Names: brand name: Scope guide

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Olympus
• Investigators: Principal Investigator: Peter Klare, MD, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany; Study Director: Stefan von Delius, MD, Klinikum rechts der Isar der Technischen Universitat Munchen

Publications and helpful links

General Publications

• Klare P, Hartrampf B, Haller B, Schlag C, Geisler F, Abdelhafez M, Einwachter H, Bajbouj M, Schmid RM, von Delius S. Magnetic endoscope imaging for routine colonoscopy: impact on propofol dosage and patient safety - a randomized trial. Endoscopy. 2016 Oct;48(10):916-22. doi: 10.1055/s-0042-110933. Epub 2016 Jul 21.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): November 6, 2015
• Last Update Submitted That Met QC Criteria: November 5, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Colonoscopy; Sedation; Propofol; Scope guide
• Other Study ID Numbers: MEXICO