Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography

Technical University of Munich144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

144

Conditions

Gastrointestinal Endoscopy Sedation

Interventions

BIS monitoringDEVICE

Neuromonitoring of depth of sedation with Bispectral Index

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%)

Locations (1)

Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

Cardiopulmonary complications of sedation

Time frame: 1-4 hours

Secondary Outcomes

Efficacy of sedation

Time frame: 1-4 hours

Data from ClinicalTrials.gov

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