Clinical trial NCT01934088: Satisfaction With Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl Sedation for Endoscopy
Official title: Nurse Administered Propofol Sedation vs. Standard Therapy for Colonoscopy in Patients With IBD. A Randomised Controlled Study on Satisfaction and Adherence to Treatment Program.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammatory Bowel Disease
Endoscopy
Sedation
Keywords: Inflammatory Bowel disease
IBD
Sedation
NAPS
Propofol
Midazolam
Satisfaction
Feasibility
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction
timeFrame: Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission
Secondary outcomes:
measure: Pre-disposing factors for satisfaction with procedure and sedation
timeFrame: At admission to the hospital at time 0
Other outcomes:
measure: Correlation between quality of sedation and satisfaction
timeFrame: At the end of procedure, an expected average of 1 hour after admission
measure: Feasibilty of method
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 hours
Locations:
city: Herlev
country: Denmark
facility: Endoscopy, Gastrounit, Herlev Hospital
state: Region H
Study officials:
affiliation: Gastroenheden D, endoscopy, Herlev Hospital
name: Jeppe Thue Jensen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenheden D, Endoscopy, Herlev Hospital
name: Peter Vilmann, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.