A Phase 4 interventional study of Propofol sedation and Midazolam and Fentanyl sedation in Flexible Bronchoscopy, Sedation and Satisfaction, sponsored by Copenhagen University Hospital at Herlev. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-30.
Sponsored by Copenhagen University Hospital at Herlev · Phase 4, Interventional, and Treatment
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.
144 studies on the registry are indexed under Personal Satisfaction; 49 are open to participants now.
This study's planned enrollment of 128 is above the median of 91 across 120 interventional studies indexed under Personal Satisfaction.
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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
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
Also known as: ATC code: N01AX10, CAS no: 2078-54-8
Also known as: Midazolam:, ATC code: N05CD08, CAS no: 59467-70-8, Fentanyl:, ATC code: N01AH01, CAS no: 437-38-7
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.
Time frame: At discharge, on average 30 minutes after procedure termination.
Number of adverse events as a surrogate marker of safety.
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.
Time frame: During procedure. On average 20 minutes.
Patient comfort
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.
Time frame: Per-operatively, on average 20 minutes
This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital at Herlev