Contact information
Type
Scientific
Primary contact
Dr Philip Barclay
ORCID ID
Contact details
Anaesthesia Department
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 708 9988
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0128125461
Study information
Scientific title
Antiemetic efficacy of combination Cyclizine-Morphine patient controlled analgesia in postoperative major gynaecological surgery patients
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Prospective randomised double blind controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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 names
Cyclizine, Morphine
Primary outcome measures
Assessment of nausea and vomiting, pain scores, morphine requirements, sedation, the need for rescue antiemetic medication, incidence of side effects
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/11/2003
Overall trial end date
10/04/2004
Reason abandoned
Eligibility
Participant inclusion criteria
90 subjects will be recruited in total, between 18-65 years old.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
90
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
10/11/2003
Recruitment end date
10/04/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthesia Department
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Liverpool Women's Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary