NCT01747733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

December 7, 2012

Last Update Submit

February 18, 2016

Conditions

Sedation

Keywords

EndoscopyERCPPCSSedationBispectral index

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Endoscopy patients

Patients undergoing endoscopy in the endoscopy unit in HUCH (Helsinki University Central Hospital).

Device: Bispectral Index

Interventions

Bispectral IndexDEVICE

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.

Endoscopy patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing endoscopic procedures requiring anaesthesist administered sedation in the endoscopy unit in HUCH

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Finland

Location

Related Publications (1)

  • Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia 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.

    PMID: 21295639BACKGROUND

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Jarno Jokelainen', M.D.

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 12, 2012

Study Start

December 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

FI(1)