Assessment of Sedation During Endoscopy
|ClinicalTrials.gov Identifier: NCT01747733|
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : February 19, 2016
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.
|Condition or disease||Intervention/treatment|
|Sedation||Device: Bispectral Index|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Assessment of Sedation During Endoscopy, a Prospective Validation Study|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747733
|Helsinki University Central Hospital|
|Principal Investigator:||Jarno Jokelainen', M.D.||Helsinki University Central Hospital|