Status:
COMPLETED
Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy
Lead Sponsor:
Daniel Franzen
Collaborating Sponsors:
B. Braun Melsungen AG
Conditions:
Lung Cancer
Sarcoidosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
After randomization, the subjects undergo flexible bronchoscopy either with fractionated propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate, oxygen saturation, and...
Detailed Description
In daily clinical praxis, propofol sedation is given manually in repeated doses (fractionated) by a specially-trained nurse in attendance of the bronchoscopist. But, fractionated propofol administrati...
Eligibility Criteria
Inclusion
- Subjects undergoing a planned, ambulatory flexible bronchoscopy (for transbronchial lung biopsy or endobronchial ultrasound guided procedures) in moderate sedation, aged between 18 and 85 years
Exclusion
- History of solid organ or bone marrow transplantation with the use of an immunosuppressive therapy
- HIV infection on anti-retroviral therapy
- Alcohol consumption more than two standard drinks per day
- Use of illicit drugs (heroin, opiates)
- Any contraindication to use propofol for sedation (e.g. allergy)
- Body mass index \> 35 kg/m2
- Mental disorder preventing appropriate judgment concerning study participation
- Missing written patient's informed consent
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT02246023
Start Date
January 1 2015
End Date
February 1 2016
Last Update
April 14 2016
Active Locations (1)
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1
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091