Overview

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

Status:
Unknown status
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Copenhagen University Hospital at Herlev
Treatments:
Fentanyl
Midazolam
Propofol
Criteria
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