Endoscopy, Inflammatory Bowel Disease, Sedation
Conditions
Keywords
Inflammatory Bowel disease, IBD, Sedation, NAPS, Propofol, Midazolam, Satisfaction, Feasibility
Brief summary
Sedation for endoscopy is a service more than a necessity. Therefore it should be patient driven. Patients with inflammatory bowel disease (IBD) undergoes life long endoscopic control. Therefore, satisfaction with the procedure experience is paramount for patients with IBD. Investigators wish to study the feasibility and the effect on patient experience of two drugs. Propofol administered by endoscopy nurses (NAPS) and conventional therapy with a combination of fentanyl and midazolam. Investigators hypothesize that patients sedated with propofol has a better procedure experience, that a well performed sedation equals a better experience and that NAPS is as feasible as fentanyl with midazolam sedation.
Interventions
DRUGPropofol
DRUGMidazolam
DRUGFentanyl
Sponsors
Copenhagen University Hospital at Herlev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Inflammatory Bowel Disease (IBD) or suspected IBD * Planned Endoscopy * Candidate for propofol sedation * willingness to be randomized * Ability to complete questionnaire
Exclusion criteria
* Allergy to drugs * American Society of Anesthesiologists Class III * Body Mass Index \> 35 * Ventricular retention * Acute condition * Severe Chronic obstructive pulmonary disease * Sleep apnea * Potentially difficult airway or previous difficulty with anesthesia * Pregnancy * \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction | Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission | Satisfaction points in a post procedure questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-disposing factors for satisfaction with procedure and sedation | At admission to the hospital at time 0 | pre-operative questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between quality of sedation and satisfaction | At the end of procedure, an expected average of 1 hour after admission | Sedation efficacy is measured through use of a previously developed competency assessment tool. The quality of sedation score. The score is correlated with patient satisfaction |
| Feasibilty of method | participants will be followed for the duration of hospital stay, an expected average of 2 hours | Timespand from entering the OR until discharge. Safety parameters during sedation. Number of adverse events, number of airway interventions, number of rescue treatments |
Countries
Denmark
Outcome results
None listed