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
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|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||April 2016|
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
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
- 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.
- 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.
- 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.
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
|Contact: Jeppe Thue Jensen, MDfirstname.lastname@example.org|
|Contact: Paul F Clementsen, Professor||0045 39 77 39 email@example.com|
|Hellerup, Denmark, 2900|
|Contact: Paul F Clementsen, Professor 0045 39 77 39 77 firstname.lastname@example.org|
|Sub-Investigator: Paul Clementsen, MD|
|Sub-Investigator: Valentina Minddal, MD|
|Principal Investigator:||Paul F Clementsen, Professor||University of Copenhagen at Gentofte Hospital|