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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01934088
Recruitment Status : Completed
First Posted : September 4, 2013
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Jeppe Thue Jensen, Copenhagen University Hospital at Herlev

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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Endoscopy Sedation Drug: Propofol Drug: Midazolam Drug: Fentanyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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: Midazolam
Other Name: Midazolam "Hameln" ATC-code: N05CD08

Drug: Fentanyl
Other Name: Fentanyl "Hameln" ATC-code: N01AH01




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pre-disposing factors for satisfaction with procedure and sedation [ Time Frame: At admission to the hospital at time 0 ]
    pre-operative questionnaire


Other Outcome Measures:
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934088


Locations
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Denmark
Endoscopy, Gastrounit, Herlev Hospital
Herlev, Region H, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
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Principal Investigator: Jeppe Thue Jensen, MD Gastroenheden D, endoscopy, Herlev Hospital
Study Director: Peter Vilmann, Professor Gastroenheden D, Endoscopy, Herlev Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeppe Thue Jensen, MD, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01934088    
Other Study ID Numbers: 2013052044 v.1
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: September 29, 2015
Last Verified: September 2015
Keywords provided by Jeppe Thue Jensen, Copenhagen University Hospital at Herlev:
Inflammatory Bowel disease
IBD
Sedation
NAPS
Propofol
Midazolam
Satisfaction
Feasibility
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Fentanyl
Midazolam
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action