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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Assessment of Sedation During Endoscopy, a Prospective Validation Study|
- level of sedation [ Time Frame: 1 day ] [ Designated as safety issue: No ]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
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Patients undergoing endoscopy in the endoscopy unit in HUCH (Helsinki University Central Hospital).
Device: Bispectral Index
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747733
|Helsinki University Central Hospital||Recruiting|
|Contact: Jarno Jokelainen, M.D. firstname.lastname@example.org|
|Principal Investigator: Jarno Jokelainen, M.D.|
|Principal Investigator:||Jarno Jokelainen', M.D.||Helsinki University Central Hospital|