Skip to main content
OpenTrials
Completed

NCT Number: NCT00952458

Bispectral Index 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Endoscopy Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

BIS monitoring

Device

Neuromonitoring of depth of sedation with Bispectral Index

Primary outcomes

  1. Cardiopulmonary complications of sedation

    Time frame: 1-4 hours

Secondary outcomes

  1. Efficacy of sedation

    Time frame: 1-4 hours

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

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

Acronym: EndoBISs

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2009
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.