Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0224112482
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised double blind 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
Combination granisetron and cyclizine anti-emetic therapy versus single use granisetron or cyclizine
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
To see if the combination anti-emetic regime reduces post-operative nausea and vomiting.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients over 18 years of age undergoing a day case gynaecological procedure.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Added January 2009: 960
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2002
Recruitment end date
01/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Anaesthetist
Torquay
TQ2 7AA
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Devon Healthcare 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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17042842
Publication citations
-
Results
Johns RA, Hanousek J, Montgomery JE, A comparison of cyclizine and granisetron alone and in combination for the prevention of postoperative nausea and vomiting., Anaesthesia, 2006, 61, 11, 1053-1057, doi: 10.1111/j.1365-2044.2006.04794.x.