Flexible Bronchoscopy, Safety, Satisfaction, Sedation
Conditions
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.
Interventions
DRUGMidazolam and Fentanyl sedation
Sponsors
Copenhagen University Hospital at Herlev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with sedation | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events as a surrogate marker of safety. | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient comfort | 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. |
Countries
Denmark
Contacts
Primary ContactJeppe Thue Jensen, MD
Backup ContactPaul F Clementsen, Professor
Outcome results
None listed