Failed Conscious Sedation During Procedure
Conditions
Keywords
Sedation, Colonoscopy, Propofol, Scope guide
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.
Interventions
DEVICEMagnetic Endoscope Imaging (Scope Guide)
Sponsors
Olympus
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Propofol dose | 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
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemia | 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. |
| Adenoma detection rate | up to one day | — |
Countries
Germany
Outcome results
None listed