Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
24/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Sushil Maslekar

ORCID ID

Contact details

Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes