Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Assessment of Sedation During Endoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jarno Jokelainen, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01747733
First received: December 7, 2012
Last updated: February 18, 2016
Last verified: February 2016
  Purpose

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 Intervention
Sedation
Device: Bispectral Index

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Sedation During Endoscopy, a Prospective Validation Study

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 200
Study Start Date: December 2013
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: December 7, 2012
Last Updated: February 18, 2016
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
Endoscopy
ERCP
PCS
Sedation
Bispectral index

ClinicalTrials.gov processed this record on December 02, 2016