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NCT01747733 Clinical Trial

Assessment of Sedation During Endoscopy

Sedation Clinical Trial

Official title:
Assessment of Sedation During Endoscopy, a Prospective Validation Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01747733
Other study ID # DNRO 336/13/03/02/2012
Secondary ID
Status Completed
Phase N/A
First received December 7, 2012
Last updated February 18, 2016
Start date December 2013
Est. completion date February 2016

Study information
Verified date February 2016
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics CommitteeFinland: Finnish Medicines Agency
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

All patients undergoing endoscopic procedure in the endoscopy unit in HUCH

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Finland Helsinki University Central Hospital Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Mazanikov M, Udd M, Kylänpää L, Lindström O, Aho P, Halttunen J, Färkkilä M, Pöyhiä R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary level of sedation 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 1 day No
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