Decreased time on mechanical ventilation when comparing analgesia-based sedation using remifentanil versus standard hypnotic-based sedation for up to 10 days in intensive care unit patients: a randomised trial.
| ISRCTN | ISRCTN47583497 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47583497 |
| Protocol serial number | USA30226 |
| Sponsor | GlaxoSmithKline |
| Funder | GlaxoSmithKline (GSK) |
- Submission date
- 09/02/2005
- Registration date
- 09/02/2005
- Last edited
- 16/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Kirkham
Scientific
Scientific
GlaxoSmithKline
Greenford Road
Greenford, Middlesex
UB6 OHE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Medical or surgical patients requiring intensive care. |
| Intervention | Comparing analgesia-based sedation using remifentanil versus standard hypnotic-based sedation for up to 10 days in intensive care unit patients. Titration of analgesia/sedation to achieve optimal sedation. Regular assessments of haemodynamics. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Remifentanil |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | Critically ill patients requiring 3-10 days of mechanical ventilation. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 07/06/2002 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- Austria
- Belgium
- Denmark
- France
- Germany
- Greece
- Iran
- Netherlands
- Portugal
- United Arab Emirates
Study participating centre
GlaxoSmithKline
Greenford, Middlesex
UB6 OHE
United Kingdom
UB6 OHE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/06/2005 | Yes | No |