Propofol versus Propofol plus Hydrocodone sedation in flexible bronchoscopy
| ISRCTN | ISRCTN81533083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81533083 |
| Protocol serial number | NA |
| Sponsor | University Hospital Basel (Switzerland) |
| Funder | University Hospital Basel (Switzerland) - Clinic for Pulmonary Medicine and Respiratory Cell Research |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled double blind intervention study |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Cough score during the procedure as estimated by the physician using a visual-analogue-scale (VAS) |
| Key secondary outcome measure(s) |
1. Total dose of propofol |
| Completion date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
