Clinical trial NCT02121704: Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Conscious Sedation During Procedure
Keywords: Sedation
Colonoscopy
Propofol
Scope guide
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Olympus
First posted: 2014-04-23
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Propofol dose
timeFrame: up to one day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)
Secondary outcomes:
measure: Hypoxemia
timeFrame: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)
measure: Adenoma detection rate
timeFrame: up to one day
Other outcomes:
Locations:
city: München
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
state: Deutschland
Study officials:
affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
name: Peter Klare, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum rechts der Isar der Technischen Universität München
name: Stefan von Delius, MD
role: STUDY_DIRECTOR
References:
citation: 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.