University Ulm
Ulm, 89081, Germany
NCT Number: NCT03860779
Nurse-administered propofol sedation has become the standard procedure for colonoscopy in Germany. Although patient satisfaction with this method is high, there is little data about the satisfaction of the examiner and factors that might negatively influence this satisfaction. Often due to the fact that the sedated patient usually expresses pain by movements of the body and paralinguistic sounds the examination has to pause until the next propofol bolus induces a deeper sedation. In order to measure the correlation of examiner satisfaction and negative factors the investigators initiated this prospective observational study. During this study examiner satisfaction and the correlation with observer reported pain (movements and paralinguistic sounds) will be measured. Additionally different biopotentials (electromyography, skin conductance level, body temperature, pulse) of the patient will be recorded during the examination and feature pattern will be correlated to the observer reported pain in order to detect pain before the expression of pain leads to a pause in the colonoscopy examination. Other factors that might influence examiner satisfaction, like duration to reach the caecum and duration of polypectomy will additionally be evaluated.
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Notify Me18 year and older
All sexes
Observational
Ulm, 89081, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 day
Correlation between Clinician Satisfaction with Sedation Instrument (CSSI) and observer reported pain (movements and paralinguistic sounds) during sedation
Time frame: 1 day
Prediction of observer reported pain events (movements and paralinguistic sounds) by biopotential feature pattern.
Time frame: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and sedation depth measured by Modified Observer's assessment of Alertness/Sedation Score
Time frame: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use measured in relation to total examination duration.
Time frame: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count
Time frame: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time
Time frame: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum
Time frame: 1 day
Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse
University of Ulm
Other
Acronym: BCSSC
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