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Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy (BCSSC)

U

University of Ulm

Status

Completed

Conditions

Bowel Disease

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age above 18
  • ASA classification I to II
  • Indication for colonoscopy with propofol sedation
  • Written informed consent

Exclusion criteria

  • Pregnancy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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