NCT03860779

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

February 28, 2019

Last Update Submit

May 9, 2020

Conditions

Bowel Disease

Keywords

colonoscopybiosignalspainsedation

Outcome Measures

Primary Outcomes (2)

  • Correlation between clinician satisfaction with sedation and pain experienced during colonoscopy

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

    1 day

  • Prediction of observer reported pain by biopotential feature pattern

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

    1 day

Secondary Outcomes (6)

  • Correlation between clinician satisfaction with sedation (CSSI) and sedation depth

    1 day

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

    1 day

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

    1 day

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

    1 day

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

    1 day

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled at the University Hospital for a colonoscopy using propofol sedation.

You may qualify if:

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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • Hann A, Gruss S, Goetze S, Mehlhase N, Frisch S, Walter B, Walter S. Autonomous Nervous Response During Sedation in Colonoscopy and the Relationship With Clinician Satisfaction. Front Med (Lausanne). 2021 Jun 16;8:643158. doi: 10.3389/fmed.2021.643158. eCollection 2021.

    PMID: 34222272DERIVED

MeSH Terms

Conditions

Intestinal DiseasesPain

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Hann

    University Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Gastroenterologist, Department of Gastroenterology

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 4, 2019

Study Start

March 4, 2019

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

DE(1)