Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography (EndoBISs)
This study has been completed.
Sponsor:
Technische Universität München
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
| Tracking Information | |||||
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| First Received Date ICMJE | August 2, 2009 | ||||
| Last Updated Date | August 23, 2012 | ||||
| Start Date ICMJE | July 2009 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cardiopulmonary complications of sedation [ Time Frame: 1-4 hours ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00952458 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Efficacy of sedation [ Time Frame: 1-4 hours ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography | ||||
| Official Title ICMJE | Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Device: BIS monitoring
Neuromonitoring of depth of sedation with Bispectral Index |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 144 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00952458 | ||||
| Other Study ID Numbers ICMJE | 2094/08 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | II. Medizinische Klinik, Dr. Stefan von Delius, Klinikum rechts der Isar der Technischen Universität München | ||||
| Study Sponsor ICMJE | Technische Universität München | ||||
| Collaborators ICMJE | Covidien | ||||
| Investigators ICMJE |
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| Information Provided By | Technische Universität München | ||||
| Verification Date | May 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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