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Nurse Administered Propofol Sedation vs combined sedation with midazolam/fentanil for colonoscopy in patients with IBD. A randomised controlled trial of satisfaction and adhearence to treatment program.

Nurse Administered Propofol Sedation vs combined sedation with midazolam/fentanil for colonoscopy in patients with IBD. A randomised controlled trial of satisfaction and adhearence to treatment program. - Propofol vs. standard sedation for colonoscopy. A study on satisfaction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002428-17-DK
Enrollment
Unknown
Registered
2013-10-22
Start date
2013-10-04
Completion date
Unknown
Last updated
2015-12-07

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

Conditions

Satisfaction with sedation during colonoscopy in patients with inflammatory bowel disease MedDRA version: 14.1 Level: LLT Classification code 10049683 Term: Monitored anesthesia care sedation System Organ Class: 100000004865

Interventions

Trade Name: Propofol "B. Braun" Product Name: Propofol "B. Braun" Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Propofol CAS Number: 2078-54-8 Other descriptive name: PROPOFOL Concen

Sponsors

Gastroenheden D, Herlev Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Elective endoscopy due to IBD or suspected IBD 2. Willing to be randomised 3. Provide written informed consent 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 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Allergy to contents administered 2. pregnant or nursing 3. ASA II 8. Sleep apnea 9. Risk of aspiration 10. Previously difficulty with anesthesia 11. Difficult airway

Design outcomes

Primary

MeasureTime frame
Main Objective: To study if patients with inflammatory bowel disease prefer sedation with propofol or midazolam/fentanyl for their colonoscopy, and if the sedation of choice can increase adherence to treatment program;Secondary Objective: If Pre-morbid psyche affects perception and satisfaction with propofol- or midazolam/fentanyl sedation;Primary end point(s): Satisfaction score as measured by questionnaire Quality of sedation score Time consumption from admission to discharge Frequency and handling of adverse events;Timepoint(s) of evaluation of this end point: After inclusion of 200 patients. Estimated to 14 months—

Secondary

MeasureTime frame
Secondary end point(s): Assessment of pre-morbid psyche Baseline demographics drop-out characteristics risk Assessment Willingness to repeat the procedure follow-up after 6-12 months;Timepoint(s) of evaluation of this end point: After inclusion of 200 patients. Estimated to 14 months—

Countries

Denmark

Contacts

Public ContactJeppe Thue Jensen

Gastroenheden D, Herlev Hospital

jeppe.thue.jensen.01@regionh.dk004526136032

Outcome results

None listed

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