Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Nurse Administered Propofol Sedation vs. Standard Therapy for Colonoscopy in Patients With IBD. A Randomised Controlled Study on Satisfaction and Adherence to Treatment Program.

Conditions
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Inflammatory Bowel Disease, Endoscopy, Sedation

Intervention / Treatment
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* Drug: Propofol
* Drug: Midazolam
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>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 | Drug: Propofol<br> <br> |
| Active Comparator: Fentanyl and Midazolam<br>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 | Drug: Midazolam<br> <br> * Other names: Midazolam Hameln ATC-code: N05CD08;Drug: Fentanyl<br> <br> * Other names: Fentanyl Hameln ATC-code: N01AH01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-disposing factors for satisfaction with procedure and sedation | pre-operative questionnaire | At admission to the hospital at time 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel disease, IBD, Sedation, NAPS, Propofol, Midazolam, Satisfaction, Feasibility