Randomised controlled trial of patient controlled sedation for colonoscopy: entonox vs target controlled infusion of propofol

ISRCTN	ISRCTN65879800
DOI	https://doi.org/10.1186/ISRCTN65879800
Secondary identifying numbers	N0084178528

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Sushil Maslekar
Scientific

Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	Does patient controlled sedation using target controlled infusion of propofol provide an effective pain relief as that using entonox?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Analgesia
Intervention	Prospective RCT involving all patients undergoing elective colonoscopy at the Endoscopy Suite, Castle Hill Hospital.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	entonox, propofol
Primary outcome measure	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 study start date	18/10/2005
Completion date	30/10/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	20
Key inclusion criteria	All patients of both sexes undergoing elective colonoscopy will be recruited.
Key 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.
Date of first enrolment	18/10/2005
Date of final enrolment	30/10/2006

Castle Hill Hospital

Cottingham
HU16 5JQ
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

The North and South Bank Research and Development Consortium (UK), NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No