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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014