Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 27, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 30, 2015
June 1, 2015
1.1 years
August 19, 2014
June 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Satisfaction with sedation
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.
At discharge, on average 30 minutes after procedure termination.
Secondary Outcomes (1)
Number of adverse events as a surrogate marker of safety.
During procedure. On average 20 minutes.
Other Outcomes (1)
Patient comfort
Per-operatively, on average 20 minutes
Study Arms (2)
Propofol sedation
EXPERIMENTALRefract 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.
Midazolam and Fentanyl sedation
ACTIVE COMPARATOR1-2 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.
Interventions
Eligibility Criteria
You may qualify if:
- Elective flexible bronchoscopy.
- Willing to be randomised
- Provide written informed consent
You may not qualify if:
- Allergy to contents administered
- pregnant or nursing
- \<18 years of age
- Not able to complete questionnaire
- Acute condition
- severe COPD
- \> ASA II
- Sleep apnea
- Risk of aspiration
- Previously difficulty with anesthesia
- Difficult airway
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gentofte Hospital
Hellerup, 2900, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul F Clementsen, Professor
University of Copenhagen at Gentofte Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2014
First Posted
August 27, 2014
Study Start
November 1, 2014
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
June 30, 2015
Record last verified: 2015-06