Sedation With Propofol or Midazolam/Fentanyl by endoscopy nurses for endoscopic examination of the lungs.A clinical randomized trial on safety and satisfactio

Phase 1

• Conditions: Satisfaction and safety of propofol sedation during flexible bronchoscopy in patients undergoing endoscopic pulmonary investigation.; MedDRA version: 17.1Level: LLTClassification code 10049683Term: Monitored anesthesia care sedationSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-004358-12-DK
• Lead Sponsor: Gentofte Hospital, Dep. of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-22
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Elective flexible bronchoscopy.
2. Willing to be randomised
3. Provide written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate satisfaction with sedation during flexible bronchoscopy. ;Secondary Objective: To study safety of endoscopy nurse administered propofol sedation during flexible bronchoscopy. ;Primary end point(s): Pre-morbid psyche evaluation<br>Satisfaction score<br>Willingness to repeat. ;Timepoint(s) of evaluation of this end point: after inklusion of 128 patients. <br>estimated 14 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Frequency of adverse events: Hypoxia, hypo/hypertension, arrythmias, airway handling, intubation. Time to discharge. ;Timepoint(s) of evaluation of this end point: after inklusion of 128 patients. <br>estimated 14 months.