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 |
| Protocol serial number | N0224112482 |
| Sponsor | Department of Health (UK) |
| Funder | South Devon Healthcare NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind study |
| Secondary study design | Randomised controlled trial |
| 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(s) |
To see if the combination anti-emetic regime reduces post-operative nausea and vomiting. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Consultant Anaesthetist
Torquay
TQ2 7AA
United Kingdom
TQ2 7AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
