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OpenTrials
Completed

NCT Number: NCT02121704

Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

München, Deutschland, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Endoscope Imaging (Scope Guide)

Device

Other names: brand name: Scope guide

Primary outcomes

  1. Propofol dose

    Time frame: 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 outcomes

  1. Hypoxemia

    Time frame: 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.

  2. Adenoma detection rate

    Time frame: up to one day

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Olympus

Registry information

Acronym: MEXICO

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 23, 2014
Registry last updated
Nov 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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