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

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.

Study Overview

• Status: Unknown
• Conditions: Sedation; Satisfaction; Safety; Flexible Bronchoscopy
• Intervention / Treatment: Drug: Propofol sedation; Drug: Midazolam and Fentanyl sedation

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeppe Thue Jensen, MD; Phone Number: 004526136032; Email: jeppe.thue.jensen.01@regionh.dk
• Study Contact Backup: Name: Paul F Clementsen, Professor; Phone Number: 0045 39 77 39 77; Email: paul.clementsen@regionh.dk

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Recruiting
    • Gentofte Hospital
    • Contact: Paul F Clementsen, Professor; Phone Number: 0045 39 77 39 77; Email: paul.clementsen@regionh.dk
    • Sub-Investigator: Paul Clementsen, MD
    • Sub-Investigator: Valentina Minddal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Propofol sedation; Other Names: ATC code: N01AX10; CAS no: 2078-54-8
Active Comparator: 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.	Drug: Midazolam and Fentanyl sedation; Other Names: Midazolam:; ATC code: N05CD08; CAS no: 59467-70-8; Fentanyl:; ATC code: N01AH01; CAS no: 437-38-7

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital at Herlev
• Investigators: Principal Investigator: Paul F Clementsen, Professor, University of Copenhagen at Gentofte Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: August 19, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Propofol
• Other Study ID Numbers: 2013-004358-12