NCT03860779: BCSSC

Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

Completed Last updated 12 May 2020

What this trial tests

trial in Bowel Disease in 112 participants. Completed in 1 July 2019.

Timeline

4 March 2019

Primary endpoint
1 July 2019

1 July 2019

Quick facts

Lead sponsor	University of Ulm
Status	Completed
Study type	OBSERVATIONAL
Enrollment	112
Start date	4 March 2019
Primary completion	1 July 2019
Estimated completion	1 July 2019
Sites	1 location across Germany

Conditions studied

• Bowel Disease — all drugs for Bowel Disease →

Sponsor

University of Ulm

Who can join

18 and older, any sex, with Bowel Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. <b>UEG</b> Week 2020 Poster Presentations.
   · 2020 · cited 5× · PMID 33043826 · DOI 10.1177/2050640620927345
2. UEG Week 2019 Poster Presentations.
   · 2019 · cited 5× · PMID 32213001 · DOI 10.1177/2050640619854671
3. Autonomous Nervous Response During Sedation in Colonoscopy and the Relationship With Clinician Satisfaction.
   Hann A, Gruss S, Goetze S, Mehlhase N, et al · · 2021 · PMID 34222272 · DOI 10.3389/fmed.2021.643158