Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.

Study Overview
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Brief Summary
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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.

Conditions
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Flexible Bronchoscopy, Sedation, Satisfaction, Safety

Intervention / Treatment
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* Drug: Propofol sedation
* Drug: Midazolam and Fentanyl sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective flexible bronchoscopy. Willing to be randomised Provide written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol sedation<br>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<br> <br> * Other names: CAS no: 2078-54-8;|
| Active Comparator: Midazolam and Fentanyl sedation<br>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<br> <br> * Other names: CAS no: 437-38-7;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |