Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage
MEXICO
MEXICO
Sponsor study identifier
interventional
334
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
November 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2014
Actual (reported)April 23, 2014
Actual (reported)May 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 2015
Actual (reported)November 2015
Actual (reported)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)
Hypoxemia
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
München, Deutschland, 81675, Germany
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.
Peter Klare, MD
II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
Stefan von Delius, MD
Technical University of Munich
334 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2014
First Posted
April 23, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
November 6, 2015
Record last verified: 2015-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: