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

Primary Purpose

Inflammatory Bowel Disease, Endoscopy, Sedation

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Propofol
Midazolam
Fentanyl
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Inflammatory Bowel disease, IBD, Sedation, NAPS, Propofol, Midazolam, Satisfaction, Feasibility

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endoscopy, Gastrounit, Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propofol

Fentanyl and Midazolam

Arm Description

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

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

Outcomes

Primary Outcome Measures

Satisfaction
Satisfaction points in a post procedure questionnaire.

Secondary Outcome Measures

Pre-disposing factors for satisfaction with procedure and sedation
pre-operative questionnaire

Full Information

First Posted
August 12, 2013
Last Updated
September 28, 2015
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT01934088
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Endoscopy, Sedation
Keywords
Inflammatory Bowel disease, IBD, Sedation, NAPS, Propofol, Midazolam, Satisfaction, Feasibility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Experimental
Arm Description
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
Arm Title
Fentanyl and Midazolam
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Midazolam "Hameln" ATC-code: N05CD08
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Fentanyl "Hameln" ATC-code: N01AH01
Primary Outcome Measure Information:
Title
Satisfaction
Description
Satisfaction points in a post procedure questionnaire.
Time Frame
Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission
Secondary Outcome Measure Information:
Title
Pre-disposing factors for satisfaction with procedure and sedation
Description
pre-operative questionnaire
Time Frame
At admission to the hospital at time 0
Other Pre-specified Outcome Measures:
Title
Correlation between quality of sedation and satisfaction
Description
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
Time Frame
At the end of procedure, an expected average of 1 hour after admission
Title
Feasibilty of method
Description
Timespand from entering the OR until discharge. Safety parameters during sedation. Number of adverse events, number of airway interventions, number of rescue treatments
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeppe Thue Jensen, MD
Organizational Affiliation
Gastroenheden D, endoscopy, Herlev Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Vilmann, Professor
Organizational Affiliation
Gastroenheden D, Endoscopy, Herlev Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Endoscopy, Gastrounit, Herlev Hospital
City
Herlev
State/Province
Region H
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21811940
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.
Results Reference
background
PubMed Identifier
33371995
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.
Results Reference
derived

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

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