Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00952458

Acronym

EndoBISs

Enrollment

144

Registered

2009-08-06

Start date

2009-07-31

Completion date

2010-05-31

Last updated

2012-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Endoscopy, Sedation

Keywords

Safety, Midazolam and propofol sedation, ERCP, Bispectral Index monitoring

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.

Interventions

DEVICEBIS monitoring

Neuromonitoring of depth of sedation with Bispectral Index

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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%)

Design outcomes

Primary

Measure	Time frame
Cardiopulmonary complications of sedation	1-4 hours

Secondary

Measure	Time frame
Efficacy of sedation	1-4 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026