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Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage

NCT02121704 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2015-11-06

No results posted yet for this study

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.

Conditions

  • Failed Conscious Sedation During Procedure

Interventions

DEVICE

Magnetic Endoscope Imaging (Scope Guide)

Sponsors & Collaborators

  • Olympus

    collaborator INDUSTRY

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Peter Klare, MD · II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany

  • Stefan von Delius, MD · Klinikum rechts der Isar der Technischen Universität München

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-08-31
Completion
2015-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121704 on ClinicalTrials.gov