Magnetic Endoscope Imaging in Colonoscopy: Influence on Propofol Dosage

Failed Conscious Sedation During Procedure Clinical Trial

— MEXICO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121704
• Other study ID #: MEXICO
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: November 5, 2015
• Start date: May 2014
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Failed Conscious Sedation During Procedure

Intervention

Device:
• Magnetic Endoscope Imaging (Scope Guide)

Locations

Country	Name	City	State
Germany	II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München	München	Deutschland

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	Olympus

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Hypoxemia	Oxygen saturation will be measured for the duration of colonoscopy/hospital stay.	up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)	Yes
Secondary	Adenoma detection rate		up to one day	No