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

September 28, 2015 updated by: Jeppe Thue Jensen, Copenhagen University Hospital at Herlev

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region H
      • Herlev, Region H, Denmark, 2730
        • Endoscopy, Gastrounit, Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol
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
Active Comparator: Fentanyl and Midazolam
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: Fentanyl
Other Names:
  • Fentanyl "Hameln" ATC-code: N01AH01
Drug: Midazolam
Other Names:
  • Midazolam "Hameln" ATC-code: N05CD08

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction
Time Frame: Participants will be interviewed when an Aldrete recovery score of 12 is achieved, an expected average of 2 hours after admission
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
Time Frame: At admission to the hospital at time 0
pre-operative questionnaire
At admission to the hospital at time 0

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between quality of sedation and satisfaction
Time Frame: At the end of procedure, an expected average of 1 hour after admission
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
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Jeppe Thue Jensen, MD, Gastroenheden D, Endoscopy, Herlev Hospital
  • Study Director: Peter Vilmann, Professor, Gastroenheden D, Endoscopy, Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013052044 v.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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