Bolus administration versus continuous infusion of Propofol sedation in flexible bronchoscopy
| ISRCTN | ISRCTN66129676 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66129676 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/02/2011
- Registration date
- 03/05/2011
- Last edited
- 27/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Daiana Stolz
Scientific
Scientific
Clinic of Pneumology and Respiratory Cell Research
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
Study information
| Study design | Prospective randomised non-inferiority single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Bolus administration versus continuous infusion of Propofol sedation in flexible bronchoscopy: a randomised non-inferiority trial |
| Study acronym | Propofol Study |
| Study objectives | 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(s) | The study protocol has been submitted to the Ethics Committee, Basel, Switzerland |
| Health condition(s) or problem(s) studied | Pulmonary disease diagnosis, need for flexible bronchoscopy |
| Intervention | Propofol continous infusion versus bolus for sedation in flexible bronchoscopy |
| Intervention type | Other |
| 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 study start date | 01/04/2011 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 702 |
| Key inclusion criteria | 1. Patients aged 18 or older 2. Patients undergoing flexible bronchoscopy |
| Key exclusion criteria | 1. Known allergy to propofol 2. Mental disorder preventing appropriate judgment concerning study participation 3. Pregnancy and breast-feeding 4. Intubated patients |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Clinic of Pneumology and Respiratory Cell Research
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
University/education
University/education
c/o Prof. Michael Tamm
Clinic of Pneumology and Respiratory Cell Research
University Hospital Basel
Petersgraben 4
4031 Basel
4031
Switzerland
"ROR" |
https://ror.org/04k51q396 |
|---|
Funders
Funder type
University/education
University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2014 | Yes | No |
