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OpenTrials
Completed

NCT Number: NCT03860779

Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Ulm

Ulm, 89081, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy

    Time frame: 1 day

    Correlation between Clinician Satisfaction with Sedation Instrument (CSSI) and observer reported pain (movements and paralinguistic sounds) during sedation

  2. Prediction of observer reported pain by biopotential feature pattern

    Time frame: 1 day

    Prediction of observer reported pain events (movements and paralinguistic sounds) by biopotential feature pattern.

Secondary outcomes

  1. Correlation between clinician satisfaction with sedation (CSSI) and sedation depth

    Time frame: 1 day

    Correlation between clinician satisfaction with sedation (CSSI) and sedation depth measured by Modified Observer's assessment of Alertness/Sedation Score

  2. Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use

    Time frame: 1 day

    Correlation between clinician satisfaction with sedation (CSSI) and frequency of sedation use measured in relation to total examination duration.

  3. Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count

    Time frame: 1 day

    Correlation between clinician satisfaction with sedation (CSSI) and resected polyp count

  4. Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time

    Time frame: 1 day

    Correlation between clinician satisfaction with sedation (CSSI) and total polyp resection time

  5. Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum

    Time frame: 1 day

    Correlation between clinician satisfaction with sedation (CSSI) and time to reach caecum

  6. Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse

    Time frame: 1 day

    Correlation between clinician satisfaction with sedation (CSSI) and years of experience of assisting nurse

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Acronym: BCSSC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2019
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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