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NCT00952458 Clinical Trial

Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

Sedation Clinical Trial

— EndoBISs  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00952458
Other study ID # 2094/08
Secondary ID
Status Completed
Phase N/A
First received August 2, 2009
Last updated August 23, 2012
Start date July 2009
Est. completion date May 2010

Study information
Verified date May 2010
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 144
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• BIS monitoring
Neuromonitoring of depth of sedation with Bispectral Index

Locations
Country Name City State
Germany Klinikum rechts der Isar der Technischen Universität München Munich Bavaria

Sponsors (2)
Lead Sponsor Collaborator
Technische Universität München Medtronic - MITG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. doi: 10.1038/ajg.2008.73. Epub 2009 Jan 20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiopulmonary complications of sedation 1-4 hours Yes
Secondary Efficacy of sedation 1-4 hours No
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