Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00952458
NCT00952458
Completed
Not Applicable

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

Technical University of Munich1 site in 1 country144 target enrollmentJuly 2009
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsGastrointestinal EndoscopySedation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Endoscopy
Sponsor
Technical University of Munich
Enrollment
144
Locations
1
Primary Endpoint
Cardiopulmonary complications of sedation
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
May 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Technical University of Munich

Eligibility Criteria

Inclusion Criteria

  • •Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation

Exclusion Criteria

  • •Missing informed consent
  • •Preexisting neurological deficit
  • •Known pregnancy
  • •Hypotension (RRsys\<90mmHg), bradycardia (HR\<50/min), hypoxia (SaO2\<90%)

Outcomes

Primary Outcomes

Cardiopulmonary complications of sedation

Time Frame: 1-4 hours

Secondary Outcomes

  • Efficacy of sedation(1-4 hours)

Study Sites (1)

Loading locations...

Similar Trials

Terminated
Not Applicable
Use of Bispectral Index (BIS) for Monitoring of Total Intravenous Anaesthesia in Pediatric PatientsAnesthesia, General
NCT01043952Aalborg University Hospital157
Unknown
Phase 4
Bispectral Index (BIS) Monitoring in Abdominal SurgeryAnesthesia
NCT01470898University Hospital Dubrava40
Recruiting
Not Applicable
Observational study of bispectral index monitoring as an adjunct to dexmedetomidine deep sedation for endoscopic treatment
JPRN-UMIN000042125St. Marianna University, School of Medicine Toyoko Hospital30
Not yet recruiting
Not Applicable
IN SURGERIES PERFORMED UNDER GENERAL ANESTHESIA,WE WILL USE ANESTHETIC GAS AND DRUG ACCORDING TO DEPTH OF ANESTHESIA BY USING A SCALE WHICH IS CALLED BISPECTRAL INDEX MONITORING
CTRI/2020/07/026476INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES
Completed
Not Applicable
The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated PatientsIntensive CareMechanically Ventilated PatientsSedated Patients
NCT01997931Bayside Health50