Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography (EndoBISs)

Technical University of Munich

Status: Completed

Conditions: Gastrointestinal Endoscopy; Sedation

Treatments: Device: BIS monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00952458

2094/08

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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%)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

BIS monitoring

Experimental group

Description:

Dosing of sedatives with BIS monitoring

Treatment:

Device: BIS monitoring

Standard monitoring

No Intervention group

Description:

Dosing of sedatives without BIS monitoring