Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Bolus administration versus continuous infusion of Propofol sedation in flexible bronchoscopy: a randomised non-inferiority trial
Acronym
Propofol Study
Study hypothesis
Propofol is a sedative-hypnotic with a rapid onset of action coupled with smooth and rapid recovery. Multiple studies using it as a sedative agent for gastrointestinal endoscopic procedures have shown propofol to be safe and effective. More recently propofol-only sedation was shown to be a feasible and safe sedation method for bronchoscopic procedures as well. In the vast majority of studies an intermittent bolus technique was used. Hardly any data exists for the use of propofol using a continuous infusion as the sedation method in bronchoscopy. To show that for sedation in flexible bronchoscopy the use of propofol using a continuous infusion is associated with a incidence of complications within 5% of that of an intermittent bolus technique, or better.
Ethics approval
The study protocol has been submitted to the Ethics Committee, Basel, Switzerland
Study design
Prospective randomised non-inferiority single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pulmonary disease diagnosis, need for flexible bronchoscopy
Intervention
Propofol continous infusion versus bolus for sedation in flexible bronchoscopy
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Number (percentage) of complications (oxygen desaturation less than or equal to 90%
2. Need for chin-support
3. Need for nasopharyngeal or oropharyngeal airway insertion
4. Need for intubation
5. Hypotension with a systolic blood pressure of less than 90 mmHg
6. Minor or major bleeding
7. Intensive Care Unit [ICU] need post-bronchoscopy
8. Pneumothorax
9. Need to abort bronchoscopy
10. Death
These outcomes are assessed by the study physician during and up to 24 hours after the procedure
Secondary outcome measures
1. Total dose of propofol,dose of propofol per kilogram body weight and per minute
2. Duration of the procedure
3. Mean lowest oxygen saturation during the procedure
4. Mean lowest systolic blood pressure during the procedure
5. Hemodynamic parameters other than blood pressure during and after the procedure
6. Cough scores, as assessed by a Visual Analogue Scale (VAS) by patients, nurses and physicians during and 2 hours after the procedure
7. Patient discomfort
8. Median patient overall well-being (comfort) at 1 and 2 hours after the procedure
9. Willingness to undergo a repeated procedure, assessed by a VAS 2 hours after the procedure
10. Fear of undergoing a repeated procedure, assessed by a VAS 2 hours after the procedure
11. Supplemental lidocaine doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist
12. Medication doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist
Overall trial start date
01/04/2011
Overall trial end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients aged 18 or older
2. Patients undergoing flexible bronchoscopy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
702
Participant exclusion criteria
1. Known allergy to propofol
2. Mental disorder preventing appropriate judgment concerning study participation
3. Pregnancy and breast-feeding
4. Intubated patients
Recruitment start date
01/04/2011
Recruitment end date
30/09/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
Clinic of Pneumology and Respiratory Cell Research
Basel
4031
Switzerland
Funders
Funder type
University/education
Funder name
University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23900984
Publication citations
-
Results
Grendelmeier P, Tamm M, Pflimlin E, Stolz D, Propofol sedation for flexible bronchoscopy: a randomised, noninferiority trial., Eur. Respir. J., 2014, 43, 2, 591-601, doi: 10.1183/09031936.00200412.