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ISRCTN
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ISRCTN18556628
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ClinicalTrials.gov identifier
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Public title
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A study to establish the efficacy of dexamethasone used in combination with cyclizine in the prevention of post operative nausea and vomiting
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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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N0355092655
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Study hypothesis
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To investigate whether cyclizine is more effective than placebo in preventing post operative nausea and vomiting. A secondary aim is to establish whether a combination of cyclizine and dexamethasone is more effective than cyclizine alone.
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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: Nausea and vomiting
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Participants - inclusion criteria
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Women over the age of 18 undergoing daycase gynaecological laparoscopy.
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Participants - exclusion criteria
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1. Failure to consent
2. Under 18 years old
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Anticipated start date
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12/02/2001
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Anticipated end date
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03/12/2003
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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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150
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Interventions
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1. Cyclizine 50mgs per-operatively and rescue ondansatron (control)
2. Dexamethasone 8mgs and cyclizine 50 mgs per-operatively and rescue ondansatron prn (combination)
3. 0.9% saline (placebo).
Randomisation: closed envelope technique. Anaesthetic: Propofol induction, nitrous oxide, isoflurane maintenance, Fentanyl 2 mgs/kg, Diclofenac 75 mgs I.v unless contraindicated. Patient airway maintained as deemed appropriate by the anaesthetist (recorded). Patient paralysed. All patients to receive iv fluids prn per-operatively. Paracetamol and/or codeine for rescue analgesia .
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Primary outcome measure(s)
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Data and demographics recorded - age, time from LMP, smoking Hx, time from starvation, type of surgery, previous postoperative nausea and vomiting (PONV) , previous travel sickness, duration of anaesthesia, reversal used (Y/N), time to first oral intake, time to first mobilisation, time to first food, time to discharge. Vomiting (Y/N) or retching (Y/N) in recovery @ 1, 2, 3 & 4 hours, nausea (none/mild/moderate/severe) in recovery and @ 1, 2, 3 & 4 hour, pain score (non/mild/moderate/severe) in recovery and @ 1, 2, 3 & 4 hours, rescue anti emetic usage (ondansatron).
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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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Mid Essex Hospital Services NHS Trust (UK)
NHS R&D Support Funding
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Trial website
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Publications
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2004 abstract presented at Anaesthetic Research Society in Liverpool, British Journal of Anaesthesia 93 (4): 618P (2004): http://bja.oxfordjournals.org/cgi/content/citation/93/4/604P
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Contact name
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Dr
Mark
Alexander-Williams
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Address
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Mid Essex Hospital Services NHS Trust (BH)
Broomfield Hospital
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City/town
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Chelmsford
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Zip/Postcode
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CM1 7ET
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Country
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United Kingdom
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Tel
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+44 (0)1245 516034
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Fax
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+44
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Email
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mark.alexander-williams@meht.nhs.uk
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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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10/07/2008
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Date ISRCTN assigned
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30/09/2005
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