A randomised double blind study looking at combination granisetron and cyclizine anti-emetic therapy versus single use granisetron or cyclizine in day case gynaecological patients
| ISRCTN | ISRCTN75581229 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75581229 |
| Secondary identifying numbers | N0224112482 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 06/01/2009
- 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 Jane Montgomery
Scientific
Scientific
Consultant Anaesthetist
Day Surgery Unit
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
| Phone | +44 (0)1803 654310 |
|---|
Study information
| Study design | Randomised double blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Is a combination of prophylatic granisetron and cyclizine more effective in the prevention of post-operative nausea and vomiting than use as single agents in day case gynaecological patients? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Gynaecological |
| Intervention | Combination granisetron and cyclizine anti-emetic therapy versus single use granisetron or cyclizine |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | To see if the combination anti-emetic regime reduces post-operative nausea and vomiting. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2002 |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Added January 2009: 960 |
| Key inclusion criteria | Patients over 18 years of age undergoing a day case gynaecological procedure. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Anaesthetist
Torquay
TQ2 7AA
United Kingdom
TQ2 7AA
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
South Devon Healthcare NHS Trust (UK)
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 | 01/11/2006 | Yes | No |
