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

Technical University of Munich

Status: Completed

Conditions: Failed Conscious Sedation During Procedure

Treatments: Device: Magnetic Endoscope Imaging (Scope Guide)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02121704

MEXICO

Details and patient eligibility

About

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.

Enrollment: 334 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

Controll Group

No Intervention group

Description:

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.

Intervention

Active Comparator group

Description:

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.

Treatment:

Device: Magnetic Endoscope Imaging (Scope Guide)