Biopotentials for Clinician Satisfaction With Sedation in Colonoscopy

NCT ID: NCT03860779

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2019-07-01

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.

Conditions

Bowel Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Alexander Hann

Senior Gastroenterologist, Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Hann

Role: PRINCIPAL_INVESTIGATOR

University Ulm

Locations

University Ulm

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34222272 (View on PubMed)

Other Identifiers

BCSSC

Identifier Type: -

Identifier Source: org_study_id