| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN65879800 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0084178528 |
| Public title | Randomised controlled trial of patient controlled sedation for colonoscopy: entonox vs target controlled infusion of propofol |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Surgery: Analgesia |
| Study hypothesis | Does patient controlled sedation using target controlled infusion of propofol provide an effective pain relief as that using entonox? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All patients of both sexes undergoing elective colonoscopy will be recruited. |
| Participants - exclusion criteria | 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. |
| Patient information material |
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| Anticipated start date | 18/10/2005 |
| Anticipated end date | 30/10/2006 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | Prospective RCT involving all patients undergoing elective colonoscopy at the Endoscopy Suite, Castle Hill Hospital. |
| Primary outcome measure(s) | Pain score on the visual analogue scale |
| Secondary outcome measure(s) | Patient comfort, completion rate, time taken and complications, time to discharge and time for return of psychomotor function. |
| Sources of funding | The North and South Bank Research and Development Consortium
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Sushil Maslekar |
| Contact details | Castle Hill Hospital
Castle Road
Cottingham
United Kingdom
HU16 5JQ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN65879800 |
| Date last extracted from ISRCTN register | 17/04/2008 |
