Randomised Controlled Trial of patient-controlled sedation for colonoscopy: Entonox versus target-controlled infusion of propofol - RCT of patient controlled sedation for colonscopy
Phase 1
- Conditions
- COLONOSCOPY- NO SPECIFIC MEDICAL CONDITIO
- Registration Number
- EUCTR2005-003887-48-GB
- Lead Sponsor
- HULL AND EAST YORKSHIRE NHS TRUST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All patients of both sexes undergoing elective colonoscopy will be recruited
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Patients with chronic pulmonary disease,
2. History of colonic resection,
3. Intolerance to any of the drugs,
4. Unwilling to enter the trial
5. ASA class IV,
6. Allergy to soybeans, eggs,
7. History of seizure disorder, sleep apnoea, or difficult intubation, a short thick neck, and inability to open mouth widely.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate and compare the analgesia/sedation achieved using inhaled entonox or target controlled infusion of propofol during colonoscopy.;<br> Secondary Objective: To ascertain if conscious sedation with entonox / propofol is associated with significantly less complications.<br> To investigate if there is a faster recovery of psychomotor function with entonox and propofol facilitating early discharge from the endoscopic suite<br> ;<br> Primary end point(s): The primary endpoint used to measure the outcome in this study would be<br> adequate pain relief as measured on the validated visual analogue scale.<br><br>
- Secondary Outcome Measures
Name Time Method