NCT00952458

Brief Summary

This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 2, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 24, 2012

Status Verified

May 1, 2010

Enrollment Period

10 months

First QC Date

August 2, 2009

Last Update Submit

August 23, 2012

Conditions

Gastrointestinal EndoscopySedation

Keywords

SafetyMidazolam and propofol sedationERCPBispectral Index monitoring

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary complications of sedation

    1-4 hours

Secondary Outcomes (1)

  • Efficacy of sedation

    1-4 hours

Study Arms (2)

BIS monitoring

EXPERIMENTAL

Dosing of sedatives with BIS monitoring

Device: BIS monitoring

Standard monitoring

NO INTERVENTION

Dosing of sedatives without BIS monitoring

Interventions

BIS monitoringDEVICE

Neuromonitoring of depth of sedation with Bispectral Index

BIS monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation

You may not qualify if:

  • Missing informed consent
  • ASA V
  • Preexisting neurological deficit
  • Known pregnancy
  • Hypotension (RRsys\<90mmHg), bradycardia (HR\<50/min), hypoxia (SaO2\<90%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Location

Related Publications (1)

  • von Delius S, Thies P, Rieder T, Wagenpfeil S, Herberich E, Karagianni A, Frimberger E, Meining A, Ludwig L, Ebert MP, Schulte-Frohlinde E, Neu B, Prinz C, Schmid RM, Huber W. Auditory evoked potentials compared with bispectral index for monitoring of midazolam and propofol sedation during colonoscopy. Am J Gastroenterol. 2009 Feb;104(2):318-25. doi: 10.1038/ajg.2008.73. Epub 2009 Jan 20.

    PMID: 19190608BACKGROUND

Study Officials

  • Stefan von Delius, MD

    Klinikum rechts der Isar der Technischen Universität München

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2009

First Posted

August 6, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 24, 2012

Record last verified: 2010-05

Locations

DE(1)