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

Phase 4

• Conditions: Flexible Bronchoscopy; Sedation; Satisfaction; Safety
• Interventions: Drug: Propofol sedation; Drug: Midazolam and Fentanyl sedation

• Registration Number: NCT02226328
• Lead Sponsor: Copenhagen University Hospital at Herlev

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Study Start: 2014-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30
• Primary Completion: 2015-12
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol sedation	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.
Midazolam and Fentanyl 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.

Primary Outcome Measures

Name	Time	Method
Satisfaction with sedation	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 Outcome Measures

Name	Time	Method
Number of adverse events as a surrogate marker of safety.	During procedure. On average 20 minutes.	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.

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Hellerup, Denmark