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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol sedation | Experimental | 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. |
|
| Midazolam and Fentanyl sedation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol sedation | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure. On average 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Per-operatively, on average 20 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeppe Thue Jensen, MD | Contact | 004526136032 | jeppe.thue.jensen.01@regionh.dk | |
| Paul F Clementsen, Professor | Contact | 0045 39 77 39 77 | paul.clementsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Paul F Clementsen, Professor | University of Copenhagen at Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gentofte Hospital | Recruiting | Hellerup | 2900 | Denmark |
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| Midazolam and Fentanyl sedation |
| Drug |
|
|
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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