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

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00952458
First received: August 2, 2009
Last updated: August 23, 2012
Last verified: May 2010
  Purpose

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.


Condition Intervention
Gastrointestinal Endoscopy
Sedation
Device: BIS monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Cardiopulmonary complications of sedation [ Time Frame: 1-4 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of sedation [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952458

Locations
Germany
Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Covidien
Investigators
Principal Investigator: Stefan von Delius, MD Klinikum rechts der Isar der Technischen Universität München
  More Information

Publications:
Responsible Party: II. Medizinische Klinik, Dr. Stefan von Delius, Klinikum rechts der Isar der Technischen Universität München
ClinicalTrials.gov Identifier: NCT00952458     History of Changes
Other Study ID Numbers: 2094/08
Study First Received: August 2, 2009
Last Updated: August 23, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Safety
Midazolam and propofol sedation
ERCP
Bispectral Index monitoring

ClinicalTrials.gov processed this record on April 16, 2014