Propofol versus midazolam/hydrocodone for sedation in flexible bronchoscopy: Safety and patient comfort - a non-inferiority trial
| ISRCTN | ISRCTN99754241 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99754241 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/01/2008
- Registration date
- 14/02/2008
- Last edited
- 02/11/2009
- 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 Michael Tamm
Scientific
Scientific
University Hospital Basel
Clinic of Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
| Phone | + 41 61 265 5184 |
|---|---|
| dstolz@uhbs.ch |
Study information
| Study design | Prospective single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Ethics Committee of Basel (Ethikkommission Beider Basel), approved on 29 August 2006 (ref: 19603) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 02/01/2008 |
| Completion date | 31/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Age >18 years 2. Need for flexible bronchoscopy |
| Key exclusion criteria | 1. Invasive mechanical ventilation 2. Known allergy or intolerance to midazolam, hydrocodone or propofol 3. Inability to provide informed consent |
| Date of first enrolment | 02/01/2008 |
| Date of final enrolment | 31/03/2008 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
University/education
University/education
c/o Prof Michael Tamm
Clinic of Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
| Phone | + 41 61 265 5184 |
|---|---|
| dstolz@uhbs.ch | |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Hospital/treatment centre
Clinic of Pulmonary Medicine and Respiratory Cell Research, University Hospital Basel (Switzerland)
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 | 01/11/2009 | Yes | No |
