Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.
NCT ID: NCT02226328
Last Updated: 2015-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
128 participants
INTERVENTIONAL
2014-11-30
2016-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Propofol sedation
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.
Midazolam and Fentanyl sedation
Interventions
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Propofol sedation
Midazolam and Fentanyl sedation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Willing to be randomised
3. Provide written informed consent
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Principal Investigators
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Paul F Clementsen, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen at Gentofte Hospital
Locations
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Gentofte Hospital
Hellerup, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Paul F Clementsen, Professor
Role: primary
Other Identifiers
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2013-004358-12
Identifier Type: -
Identifier Source: org_study_id