urse 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.

Conditions: Satisfaction with sedation during colonoscopy in patients with inflammatory bowel disease
MedDRA version: 14.1Level: LLTClassification code 10049683Term: Monitored anesthesia care sedationSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-002428-17-DK

Lead Sponsor: Gastroenheden D, Herlev Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

1. Allergy to contents administered
2. pregnant or nursing
3. <18 years of age
4. Not able to complete questionnaire
5. Acute condition
6. severe COPD
7. > ASA II
8. Sleep apnea
9. Risk of aspiration
10. Previously difficulty with anesthesia
11. Difficult airway

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Quality of sedation score<br>Time consumption from admission to discharge<br>Frequency and handling of adverse events;Timepoint(s) of evaluation of this end point: After inclusion of 200 patients. <br>Estimated to 14 months

Secondary Outcome Measures

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