Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.
Overview
- Phase
- Phase 4
- Intervention
- Propofol sedation
- Conditions
- Flexible Bronchoscopy
- Sponsor
- Copenhagen University Hospital at Herlev
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Satisfaction with sedation
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •Sleep apnea
- •Risk of aspiration
- •Previously difficulty with anesthesia
- •Difficult airway
Arms & Interventions
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.
Intervention: Propofol sedation
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.
Intervention: Midazolam and Fentanyl sedation
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of adverse events as a surrogate marker of safety.(During procedure. On average 20 minutes.)