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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Experimental | Propofol in refract doses. Induction: 10-60 mg supplemented with 10-30 mg following an age correlated algorithm. Maintenance with refract bolus of 10-20 mg every 1-2 minutes after assessed need and condition |
|
| Fentanyl and Midazolam | Active Comparator | 0.025-0.05 mg of Fentanyl i.v. minimum 5 minutes before procedure as a single shot. Midazolam 1-2 mg i.v. for induction and 0.5-1 mg i.v. for maintenance after assessing needs and condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug |
| ||
| Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction | Satisfaction points in a post procedure questionnaire. | Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-disposing factors for satisfaction with procedure and sedation | pre-operative questionnaire | At admission to the hospital at time 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between quality of sedation and satisfaction | 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 | At the end of procedure, an expected average of 1 hour after admission |
| Feasibilty of method |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeppe Thue Jensen, MD | Gastroenheden D, endoscopy, Herlev Hospital | Principal Investigator |
| Peter Vilmann, Professor | Gastroenheden D, Endoscopy, Herlev Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy, Gastrounit, Herlev Hospital | Herlev | Region H | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21811940 | Background | Jensen JT, Vilmann P, Horsted T, Hornslet P, Bodtger U, Banning A, Hammering A. Nurse-administered propofol sedation for endoscopy: a risk analysis during an implementation phase. Endoscopy. 2011 Aug;43(8):716-22. doi: 10.1055/s-0030-1256515. Epub 2011 Aug 2. | |
| 33371995 | Derived | Steenholdt C, Jensen JT, Brynskov J, Moller AM, Limschou AC, Konge L, Vilmann P. Patient Satisfaction of Propofol Versus Midazolam and Fentanyl Sedation During Colonoscopy in Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2022 Mar;20(3):559-568.e5. doi: 10.1016/j.cgh.2020.10.037. Epub 2020 Oct 22. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D008874 | Midazolam |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| Fentanyl | Drug |
|
|
Timespand from entering the OR until discharge. Safety parameters during sedation. Number of adverse events, number of airway interventions, number of rescue treatments |
| participants will be followed for the duration of hospital stay, an expected average of 2 hours |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |