Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography (EndoBISs)

August 23, 2012 updated by: Technical University of Munich

Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BIS monitoring
Dosing of sedatives with BIS monitoring
Device: BIS monitoring
Neuromonitoring of depth of sedation with Bispectral Index
NO_INTERVENTION: Standard monitoring
Dosing of sedatives without BIS monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiopulmonary complications of sedation
Time Frame: 1-4 hours
1-4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of sedation
Time Frame: 1-4 hours
1-4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Stefan von Delius, MD, Klinikum rechts der Isar der Technischen Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

August 2, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (ESTIMATE)

August 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2012

Last Update Submitted That Met QC Criteria

August 23, 2012

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2094/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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