Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

Not Applicable

Completed

• Conditions: Gastrointestinal Endoscopy; Sedation
• Interventions: Device: BIS monitoring

• Registration Number: NCT00952458
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-02
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-06
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2012-08-23
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIS monitoring	BIS monitoring	Dosing of sedatives with BIS monitoring

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary complications of sedation	1-4 hours

Secondary Outcome Measures

Name	Time	Method
Efficacy of sedation	1-4 hours

Trial Locations

Locations (1)

Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munich, Bavaria, Germany