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Assessment of Sedation During Endoscopy

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ClinicalTrials.gov Identifier: NCT01747733
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
Jarno Jokelainen, MD, Helsinki University Central Hospital

Brief 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.


Condition or disease Intervention/treatment
Sedation Device: Bispectral Index

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Endoscopy patients
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.



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing endoscopic procedures requiring anaesthesist administered sedation in the endoscopy unit in HUCH
Criteria

Inclusion Criteria:

All patients undergoing endoscopic procedure in the endoscopy unit in HUCH

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747733


Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Jarno Jokelainen', M.D. Helsinki University Central Hospital

Publications:
Responsible Party: Jarno Jokelainen, MD, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01747733     History of Changes
Other Study ID Numbers: DNRO 336/13/03/02/2012
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Jarno Jokelainen, MD, Helsinki University Central Hospital:
Endoscopy
ERCP
PCS
Sedation
Bispectral index