Contact information
Type
Scientific
Primary contact
Prof Michael Tamm
ORCID ID
Contact details
University Hospital Basel
Clinic of Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
+ 41 61 265 5184
dstolz@uhbs.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The use of propofol for sedation in flexible bronchoscopy is associated with a mean low saturation within 2% of that of the combination of midazolam and hydrocodone, or better.
Ethics approval
Ethics Committee of Basel (Ethikkommission Beider Basel), approved on 29 August 2006 (ref: 19603)
Study design
Prospective single-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sedation for flexible bronchoscopy
Intervention
Patients will be randomly assigned to propofol (intravenous; iv) or the combination of midazolam and hydrocodone (iv) for sedation during flexible bronchoscopy. The doses of propofol and midazolam vary among the patients, depending on the level of sedation obtained. Hydrocodone will be used in the standard dose of 5 mg iv.
Intervention type
Drug
Phase
Not Specified
Drug names
Propofol, midazolam and hydrocodone
Primary outcome measure
1. Mean lowest oxygen saturation during the procedure
2. Median patient overall well-being (comfort) at 1 hour after the procedure
Secondary outcome measures
1. Duration of the procedure
2. Hemodynamic parameters during and after the procedure
3. Cough scores, as assessed by a visual analogue scale by patients, nurses and physicians 2 hours after the procedure
4. Patient discomfort
5. Willigness to undergo a repeated procedure, assessed by a visual analogue scale 2 hours after the procedure
6. Fear of undergoing a repeated procedure, assessed by a visual analogue scale 2 hours after the procedure
7. Number (percentage) of complications (desaturation >90%, Chin-support, mild bledding, severe bleeding, nasopharyngeal-tube use, intubation, Intensive Care Unit [ICU] need post-bronchoscopy, hypotension, pneumothorax, death) assessed by the study physician during and up to 24 hours after the procedure
8. Supplemental lidocaine doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchosopist
9. Medication doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist
10. Median patient overall well-being (comfort) at 2 hours after the procedure
Overall trial start date
02/01/2008
Overall trial end date
31/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >18 years
2. Need for flexible bronchoscopy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Invasive mechanical ventilation
2. Known allergy or intolerance to midazolam, hydrocodone or propofol
3. Inability to provide informed consent
Recruitment start date
02/01/2008
Recruitment end date
31/03/2008
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Basel
Basel
4031
Switzerland
Sponsor information
Organisation
University Hospital Basel (Switzerland)
Sponsor details
c/o Prof Michael Tamm
Clinic of Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
+ 41 61 265 5184
dstolz@uhbs.ch
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Clinic of Pulmonary Medicine and Respiratory Cell Research, University Hospital Basel (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19386684
Publication citations
-
Results
Stolz D, Kurer G, Meyer A, Chhajed PN, Pflimlin E, Strobel W, Tamm M, Propofol versus combined sedation in flexible bronchoscopy: a randomised non-inferiority trial., Eur. Respir. J., 2009, 34, 5, 1024-1030, doi: 10.1183/09031936.00180808.