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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

August 2, 2009
August 23, 2012
July 2009
May 2010   (final data collection date for primary outcome measure)
Cardiopulmonary complications of sedation [ Time Frame: 1-4 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00952458 on ClinicalTrials.gov Archive Site
Efficacy of sedation [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Gastrointestinal Endoscopy
  • Sedation
Device: BIS monitoring
Neuromonitoring of depth of sedation with Bispectral Index
  • Experimental: BIS monitoring
    Dosing of sedatives with BIS monitoring
    Intervention: Device: BIS monitoring
  • No Intervention: Standard monitoring
    Dosing of sedatives without BIS monitoring
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. Epub 2009 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
May 2010
May 2010   (final data collection date for primary outcome measure)

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%)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00952458
2094/08
No
II. Medizinische Klinik, Dr. Stefan von Delius, Klinikum rechts der Isar der Technischen Universität München
Technische Universität München
Covidien
Principal Investigator: Stefan von Delius, MD Klinikum rechts der Isar der Technischen Universität München
Technische Universität München
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP