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

Sedation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02226328
• Other study ID #: 2013-004358-12
• Status: Recruiting
• Phase: Phase 4
• First received: August 19, 2014
• Last updated: June 29, 2015
• Start date: November 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2015
• Source: Copenhagen University Hospital at Herlev
• Contact: Jeppe Thue Jensen, MD
• Phone: 004526136032
• Email: jeppe.thue.jensen.01[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Ethics Commitee, Capital Region.Denmark: Good Clinical Practice Unit, University of Copenhagen.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Flexible Bronchoscopy
• Safety
• Satisfaction
• Sedation

Intervention

Drug:
• Propofol sedation

• Midazolam and Fentanyl sedation

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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.	No
Secondary	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.	Yes