Randomised Controlled Trial of patient-controlled sedation for colonoscopy: Entonox versus target-controlled infusion of propofol - RCT of patient controlled sedation for colonscopy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003887-48-GB

Enrollment

100

Registered

2005-10-25

Start date

2005-12-21

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COLONOSCOPY- NO SPECIFIC MEDICAL CONDITION

Interventions

Trade Name: DIPRIVAN 1% Pharmaceutical Form: Injection* Pharmaceutical form of the placebo: Inhalation gas Route of administration of the placebo: Inhal

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate and compare the analgesia/sedation achieved using inhaled entonox or target controlled infusion of propofol during colonoscopy.; Secondary Objective: To ascertain if conscious sedation with entonox / propofol is associated with significantly less complications. To investigate if there is a faster recovery of psychomotor function with entonox and propofol facilitating early discharge from the endoscopic suite ; Primary end point(s): The primary endpoint used to measure the outcome in this study would be adequate pain relief as measured on the validated visual analogue scale.	—

Measure

Time frame

Main Objective: To investigate and compare the analgesia/sedation achieved using inhaled entonox or target controlled infusion of propofol during colonoscopy.; Secondary Objective: To ascertain if conscious sedation with entonox / propofol is associated with significantly less complications. To investigate if there is a faster recovery of psychomotor function with entonox and propofol facilitating early discharge from the endoscopic suite ; Primary end point(s): The primary endpoint used to measure the outcome in this study would be adequate pain relief as measured on the validated visual analogue scale.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026