A study to establish the efficacy of dexamethasone used in combination with cyclizine in the prevention of post operative nausea and vomiting
| ISRCTN | ISRCTN18556628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18556628 |
| Protocol serial number | N0355092655 |
| Sponsor | Department of Health |
| Funders | Mid Essex Hospital Services NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 10/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Mid Essex Hospital Services NHS Trust (BH)
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom
| Phone | +44 (0)1245 516034 |
|---|---|
| mark.alexander-williams@meht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To investigate whether cyclizine is more effective than placebo in preventing post operative nausea and vomiting. A secondary aim is to establish whether a combination of cyclizine and dexamethasone is more effective than cyclizine alone. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Nausea and vomiting |
| Intervention | 1. Cyclizine 50mgs per-operatively and rescue ondansatron (control) 2. Dexamethasone 8mgs and cyclizine 50 mgs per-operatively and rescue ondansatron prn (combination) 3. 0.9% saline (placebo). Randomisation: closed envelope technique. Anaesthetic: Propofol induction, nitrous oxide, isoflurane maintenance, Fentanyl 2 mgs/kg, Diclofenac 75 mgs I.v unless contraindicated. Patient airway maintained as deemed appropriate by the anaesthetist (recorded). Patient paralysed. All patients to receive iv fluids prn per-operatively. Paracetamol and/or codeine for rescue analgesia . |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | dexamethasone, cyclizine |
| Primary outcome measure(s) |
Data and demographics recorded - age, time from LMP, smoking Hx, time from starvation, type of surgery, previous postoperative nausea and vomiting (PONV) , previous travel sickness, duration of anaesthesia, reversal used (Y/N), time to first oral intake, time to first mobilisation, time to first food, time to discharge. Vomiting (Y/N) or retching (Y/N) in recovery @ 1, 2, 3 & 4 hours, nausea (none/mild/moderate/severe) in recovery and @ 1, 2, 3 & 4 hour, pain score (non/mild/moderate/severe) in recovery and @ 1, 2, 3 & 4 hours, rescue anti emetic usage (ondansatron). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 03/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 150 |
| Key inclusion criteria | Women over the age of 18 undergoing daycase gynaecological laparoscopy. |
| Key exclusion criteria | 1. Failure to consent 2. Under 18 years old |
| Date of first enrolment | 12/02/2001 |
| Date of final enrolment | 03/12/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CM1 7ET
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? |
|---|---|---|---|---|---|
| Abstract results | abstract presented at Anaesthetic Research Society in Liverpool, British Journal of Anaesthesia 93 (4): 618P (): | 01/10/2004 | No | No |
