Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084178528
Study information
Scientific title
Acronym
Study hypothesis
Does patient controlled sedation using target controlled infusion of propofol provide an effective pain relief as that using entonox?
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
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Analgesia
Intervention
Prospective RCT involving all patients undergoing elective colonoscopy at the Endoscopy Suite, Castle Hill Hospital.
Intervention type
Drug
Phase
Not Specified
Drug names
entonox, propofol
Primary outcome measures
Pain score on the visual analogue scale
Secondary outcome measures
Patient comfort, completion rate, time taken and complications, time to discharge and time for return of psychomotor function.
Overall trial start date
18/10/2005
Overall trial end date
30/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All patients of both sexes undergoing elective colonoscopy will be recruited.
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
20
Participant 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.
Recruitment start date
18/10/2005
Recruitment end date
30/10/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
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
The North and South Bank Research and Development Consortium (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
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/19575742
Publication citations
-
Results
Maslekar S, Balaji P, Gardiner A, Culbert B, Monson JR, Duthie GS, Randomized controlled trial of patient-controlled sedation for colonoscopy: Entonox vs modified patient-maintained target-controlled propofol., Colorectal Dis, 2011, 13, 1, 48-57, doi: 10.1111/j.1463-1318.2009.01988.x.