Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084144579
Study information
Scientific title
Acronym
Study hypothesis
To compare the effectiveness of granisetrone with ondansetrone, cyclizine and placebo in the prevention of post-operative nausea and vomiting in patients undergoing "Day Surgery" under general anaesthesia.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Signs and Symptoms: Post operative nausea and vomiting (PONV)
Intervention
Patients are to continue to have general anaesthesia for their surgical procedure. Every participating patient to receive a prophylactic anti emetic, randomly selected, at the beginning of anaesthetic induction.
Anti emetics to be divided into 4 groups:
A: Cyclizine 50mgm I.V.
B: Ondansetrone 4mgm I.V.
C: Granisetrone 1mgm I.V
D: Placebo.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Post operative record of patients PONV status to be recorded by the nurse in PACU (Post anaesthetic care unit). Rescu anti-emetic to be given by the nurse in PACU as per protocol. Emesis score as follows: 0 - None; 1 - Nausea; 2 - Retching; 3 - Vomiting. Patient to complete the simple questionnaire regarding her post operative recovery and return by pre-paid envelope the next day.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2003
Overall trial end date
01/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
It is anticipated to recruit 4 groups of 30 patients each = total of 120 patients into this study.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2003
Recruitment end date
01/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Grimsby
DN33 2BA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding
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