Propofol versus Propofol plus Hydrocodone sedation in flexible bronchoscopy
| ISRCTN | ISRCTN81533083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81533083 |
| Secondary identifying numbers | NA |
- Submission date
- 05/05/2010
- Registration date
- 10/06/2010
- Last edited
- 10/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Daiana Stolz
Scientific
Scientific
University Hospital Basel
Clinic for Pulmonary Medicine and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 5184 |
|---|---|
| stolzd@uhbs.ch |
Study information
| Study design | Randomised placebo controlled double blind intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | Propofol versus Propofol plus Hydrocodone sedation in flexible bronchoscopy: a prospective, randomised, placebo-controlled, double-blind study |
| Study acronym | PROHYDE Study |
| Study objectives | The combination of propofol and hydrocodone is superior to propofol alone to suppress cough during flexible bronchoscopy. |
| Ethics approval(s) | Ethics commission of Basel (Ethikkomission beider Basel [EKBB]) approved in on the 2nd of February 2009 (ref: 29/09) |
| Health condition(s) or problem(s) studied | Sedation for flexible bronchoscopy |
| Intervention | Patients were randomly assigned to either intravenous propofol or the combination of propofol and hydrocodone (4mg). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Cough score during the procedure as estimated by the physician using a visual-analogue-scale (VAS) |
| Secondary outcome measures | 1. Total dose of propofol 2. Haemodynamic parameters 3. Patients discomfort, assessed 2 hours after procedure 4. Complications during flexible bronchoscopy 5. Patient reported side effects, assessed 24 hours after procedure |
| Overall study start date | 14/02/2009 |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Age > 18 years 2. Requirement of flexible bronchoscopy 3. Written informed consent |
| Key exclusion criteria | 1. Tracheal Intubation 2. Known allergy or intolerance to hydrocodone or propofol 3. Mental retardation 4. Pregnancy |
| Date of first enrolment | 14/02/2009 |
| Date of final enrolment | 31/01/2011 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Clinic for Pneumology and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
| Phone | +41 (0)61 265 5184 |
|---|---|
| stolzd@uhbs.ch | |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Hospital/treatment centre
University Hospital Basel (Switzerland) - Clinic for Pulmonary Medicine 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 |
