Status:
COMPLETED
Bronchoscopy and Bispectral Index (BIS) - Guided Sedation
Lead Sponsor:
University Hospital, Geneva
Collaborating Sponsors:
Centre Valaisan de Pneumologie, CH-3960Montana
Conditions:
Bronchoscopy
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief Summary
Bronchoscopy is performed on a daily basis for diagnostic and therapeutic purposes. This procedure may cause anxiety and discomfort requiring the use of sedative drugs. In this study the investigator...
Detailed Description
Sedation using anxiolytic, hypnotic and /or analgesic drugs is currently used during flexible bronchoscopy (FB) to facilitate the diagnostic process and improve patient comfort.\[The technique of seda...
Eligibility Criteria
Inclusion
- patients scheduled for bronchoscopy
- ASA I to III
- age between 18 and 79 years
- capacity of discernment
Exclusion
- visual and psychological problems that might interfere with psychometric testing
- chronic obstructive pulmonary disease with FEV1 \< 50% predicted
- need for an airway intubation or laryngeal mask insertion
- fever or other signs of systemic infection
- hemodynamic instability defined as a resting heart rate (HR) \< 60 or ≥ 120 and/or a systolic blood pressure (BP) \< 100 or \> 180 mmHg
- significant liver disease and documented soy allergy
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00839371
Start Date
January 1 2005
End Date
December 1 2007
Last Update
February 9 2009
Active Locations (1)
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1
Centre Valaisan de Pneumologie
Montana, Switzerland, CH-3960