Assessment of Sedation During Endoscopy

Completed

• Conditions: Sedation
• Interventions: Device: Bispectral Index

• Registration Number: NCT01747733
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Study Start: 2013-12
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

All patients undergoing endoscopic procedure in the endoscopy unit in HUCH

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopy patients	Bispectral Index	Patients undergoing endoscopy in the endoscopy unit in HUCH (Helsinki University Central Hospital).

Primary Outcome Measures

Name	Time	Method
level of sedation	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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland