Antiemetic efficacy of combination Cyclizine-Morphine patient controlled analgesia in postoperative major gynaecological surgery patients
| ISRCTN | ISRCTN84471191 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84471191 |
| Protocol serial number | N0128125461 |
| Sponsor | Department of Health |
| Funder | Liverpool Women's Hospital NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 31/03/2020
- 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
Dr Philip Barclay
Scientific
Scientific
Anaesthesia Department
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
| Phone | +44 (0)151 708 9988 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double blind controlled pilot study |
| Secondary study design | Randomised controlled trial |
| Scientific title | Antiemetic efficacy of combination Cyclizine-Morphine patient controlled analgesia in postoperative major gynaecological surgery patients |
| Study objectives | To compare the efficacy of combination morphine plus cyclizine patient controlled analgesia (PCA) versus morphine alone in PCA in patients undergoing major gynaecological surgery following a single prophylactic intravenous dose of cyclizine in theatre. We aim to identify the dose of cyclizine per PCA bolus that is most effective against post-operative nausea and vomiting (PONV) but has minimal side effects. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Gynaecological |
| Intervention | Compare the efficacy of combination morphine plus cyclizine patient controlled analgesia (PCA) versus morphine alone in PCA in patients undergoing major gynaecological surgery following a single prophylactic intravenous dose of cyclizine in theatre. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclizine, Morphine |
| Primary outcome measure(s) |
Assessment of nausea and vomiting, pain scores, morphine requirements, sedation, the need for rescue antiemetic medication, incidence of side effects |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target sample size at registration | 90 |
| Key inclusion criteria | 90 subjects will be recruited in total, between 18-65 years old. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 10/11/2003 |
| Date of final enrolment | 10/04/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Anaesthesia Department
Liverpool
L8 7SS
United Kingdom
L8 7SS
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 |
Editorial Notes
31/03/2020: No publications found, all search options exhausted, study status unverified.
