Assessment of Sedation During Endoscopy

Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic retrograde cholangiopancreatography). However, assessment of the level of sedation during these procedures is not investigated in detail.

The purpose of this study is to compare different sedation scales and bispectral index during sedation in endoscopic procedures in order to find the best suited assessment method for sedation under these conditions.

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Key information

Conditions

Sedation

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Central Hospital

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients undergoing endoscopic procedure in the endoscopy unit in HUCH

Exclusion criteria

Treatment and study plan

Bispectral Index

Device

use of BiS-monitor in the assessment of the level of sedation in patients receiving sedation in endoscopy procedures when compared to clinical sedation scales, such as the Richmond agitation-sedation score.

Primary outcomes

level of sedation

Time frame: 1 day

Sedation measured by Bispectral Index (BiS) compared with RASS (Richmond Agitation-Sedation Score), MOAA/S (Modified Observer's Assessment of Alertness/Sedation) and Ramsay sedation score

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Assessment of Sedation During Endoscopy, a Prospective Validation Study

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Dec 12, 2012
Registry last updated: Feb 19, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed