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ISRCTN
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ISRCTN65879800
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of patient controlled sedation for colonoscopy: entonox vs target controlled infusion of propofol
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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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N0084178528
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Study hypothesis
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Does patient controlled sedation using target controlled infusion of propofol provide an effective pain relief as that using entonox?
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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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Surgery: Analgesia
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Participants - inclusion criteria
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All patients of both sexes undergoing elective colonoscopy will be recruited.
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Participants - exclusion criteria
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Patients with chronic pulmonary disease, history of colonic resection, intolerance to any of the drugs, unwilling to enter trial, ASA class IV, allergy to soybeans, eggs, history of seizure disorder, sleep apnoea, or difficult intubation, a short thin neck or the inability to open mouth widely.
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Anticipated start date
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18/10/2005
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Anticipated end date
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30/10/2006
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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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20
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Interventions
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Prospective RCT involving all patients undergoing elective colonoscopy at the Endoscopy Suite, Castle Hill Hospital.
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Primary outcome measure(s)
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Pain score on the visual analogue scale
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Secondary outcome measure(s)
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Patient comfort, completion rate, time taken and complications, time to discharge and time for return of psychomotor function.
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Sources of funding
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The North and South Bank Research and Development Consortium
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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Mr
Sushil
Maslekar
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Address
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Castle Hill Hospital
Castle Road
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City/town
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Cottingham
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Zip/Postcode
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HU16 5JQ
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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 - 2007 Update - Department of Health
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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
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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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28/09/2007
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Last edited
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05/11/2007
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Date ISRCTN assigned
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28/09/2007
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