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ISRCTN
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ISRCTN07711014
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ClinicalTrials.gov identifier
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Public title
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Prevention of post-operative nausea and vomiting (PONV) in 'day surgery patients'; Granisetron v/s Placebo, Cyclizine and Ondansetron.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0084144579
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Signs and Symptoms: Post operative nausea and vomiting (PONV)
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2003
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Anticipated end date
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01/09/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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It is anticipated to recruit 4 groups of 30 patients each = total of 120 patients into this study.
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Bhaskar
Tandon
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Address
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Northern Lincolnshire & Goole Hospitals NHS Trust
Diana Princess of Wales Hospital
Scartho Road
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City/town
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Grimsby
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Zip/Postcode
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DN33 2BA
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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21/04/2011
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Date ISRCTN assigned
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30/09/2005
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