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Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.

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ClinicalTrials.gov Identifier: NCT02226328
Recruitment Status : Unknown
Verified June 2015 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Recruiting
First Posted : August 27, 2014
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

Brief Summary:

Flexible bronchoscopy almost always requires sedation to be successful. In order to increase the availability of propofol for sedation, non-anaesthesiologist administered propofol sedation has been suggested as an alternative to traditional midazolam/opioid sedation or the general anaesthesia provided by anaesthesiologists.

Hypothesis: Patients undergoing flexible bronchoscopy prefers non-anaesthesiologist administered sedation with propofol as opposed to non-anaesthesiologist administered sedation with midazolam and fentanyl.

Propofol sedation is as safe as midazolam and fentanyl sedation.


Condition or disease Intervention/treatment Phase
Flexible Bronchoscopy Sedation Satisfaction Safety Drug: Propofol sedation Drug: Midazolam and Fentanyl sedation Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propofol sedation

Refract bolus propofol sedation as monotherapy administered by a sedation-trained nurse endoscopist.

Induction with 10-60 mg bolus, repeated every 45-60 sec. until moderate sedation.

Maintenance with 10-20 mg of propofol in case of discomfort.

Drug: Propofol sedation
Other Names:
  • ATC code: N01AX10
  • CAS no: 2078-54-8

Active Comparator: Midazolam and Fentanyl sedation

1-2 mg of Midazolam with 0.025-0.05 mg of fentanyl for induction 10 prior to procedure initiation.

Maintenance with 1 mg Midazolam in case of discomfort.

Drug: Midazolam and Fentanyl sedation
Other Names:
  • Midazolam:
  • ATC code: N05CD08
  • CAS no: 59467-70-8
  • Fentanyl:
  • ATC code: N01AH01
  • CAS no: 437-38-7




Primary Outcome Measures :
  1. Satisfaction with sedation [ Time Frame: At discharge, on average 30 minutes after procedure termination. ]
    The average duration of bronchoscopy is estimated to 20 minutes. A validated satisfaction questionnaire will be filled by the patient at discharge from the recovery room, on average 30 minutes after completed procedure. Readiness for discharge will be assessed using an Aldrete score.


Secondary Outcome Measures :
  1. Number of adverse events as a surrogate marker of safety. [ Time Frame: During procedure. On average 20 minutes. ]
    Adverse events as a dichotomous value of "no event" or "event". Events are: The use of rescue medicine, and cardiopulmonary support per-operatively, blood pressure deviation from baseline over 30% of Mean Arterial Pressure, oxygen saturation < 90%, and arrhythmias will be recorded for the duration of the procedure.


Other Outcome Measures:
  1. Patient comfort [ Time Frame: Per-operatively, on average 20 minutes ]
    Patient discomfort/comfort will be registered on a validated scale during the procedure and recorded by the endoscopy nurse. If the procedure was unsuccessful due to discomfort, this will also be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Elective flexible bronchoscopy.
  2. Willing to be randomised
  3. Provide written informed consent

Exclusion Criteria:

  1. Allergy to contents administered
  2. pregnant or nursing
  3. <18 years of age
  4. Not able to complete questionnaire
  5. Acute condition
  6. severe COPD
  7. > ASA II
  8. Sleep apnea
  9. Risk of aspiration
  10. Previously difficulty with anesthesia
  11. Difficult airway

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): NCT02226328


Contacts
Contact: Jeppe Thue Jensen, MD 004526136032 jeppe.thue.jensen.01@regionh.dk
Contact: Paul F Clementsen, Professor 0045 39 77 39 77 paul.clementsen@regionh.dk

Locations
Denmark
Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Paul F Clementsen, Professor    0045 39 77 39 77    paul.clementsen@regionh.dk   
Sub-Investigator: Paul Clementsen, MD         
Sub-Investigator: Valentina Minddal, MD         
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Paul F Clementsen, Professor University of Copenhagen at Gentofte Hospital

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT02226328     History of Changes
Other Study ID Numbers: 2013-004358-12
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Propofol
Midazolam
Fentanyl
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