Assessment of Sedation During Endoscopy, a Prospective Validation Study

Helsinki University Central Hospital1 site in 1 country200 target enrollmentDecember 2013

ConditionsSedation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sedation
Sponsor: Helsinki University Central Hospital
Enrollment: 200
Locations: 1
Primary Endpoint: level of sedation
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

February 2016

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Helsinki University Central Hospital

Responsible Party

Principal Investigator

Jarno Jokelainen, MD

Principal Investigator

Helsinki University Central Hospital

Eligibility Criteria

Inclusion Criteria

•All patients undergoing endoscopic procedure in the endoscopy unit in HUCH

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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