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

Inflammatory Bowel Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934088
• Other study ID #: 2013052044 v.1
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2013
• Last updated: September 28, 2015
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: GCP-Unit at Copenhagen UniversityhospitalDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endoscopy
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Sedation

Intervention

Drug:
• Propofol

• Midazolam

• Fentanyl

Locations

Country	Name	City	State
Denmark	Endoscopy, Gastrounit, Herlev Hospital	Herlev	Region H

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Feasibilty of method	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	Yes
Primary	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	No
Secondary	Pre-disposing factors for satisfaction with procedure and sedation	pre-operative questionnaire	At admission to the hospital at time 0	No