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

Nurse Administered Propofol Sedation vs. Midazolam- with Fentanyl-sedation for Flexible Bronchoscopy: A randomized, Single Blind, Controlled Study of Safety and Satisfaction. - Safety of NAPS vs standard sedation for fleksible broncoscopy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004358-12-DK

Enrollment

Unknown

Registered

2013-11-22

Start date

2013-12-23

Completion date

Unknown

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Satisfaction and safety of propofol sedation during flexible bronchoscopy in patients undergoing endoscopic pulmonary investigation. MedDRA version: 17.1 Level: LLT Classification code 10049683 Term: Monitored anesthesia care sedation System Organ Class: 100000004865

Interventions

Trade Name: Propofol "B. BRAUN" Product Name: Propofol "B. Braun" Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Propofol CAS Number: 2078-54-8 Other descriptive name: PROPOFOL Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Allergy to contents administered 2. pregnant or nursing 3. ASA II 8. Sleep apnea 9. Risk of aspiration 10. Previously difficulty with anesthesia 11. Difficult airway

Design outcomes

Primary

Measure	Time frame
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 Satisfaction score Willingness to repeat. ;Timepoint(s) of evaluation of this end point: after inklusion of 128 patients. estimated 14 months.	—

Measure

Time frame

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 Satisfaction score Willingness to repeat. ;Timepoint(s) of evaluation of this end point: after inklusion of 128 patients. estimated 14 months.

—

Secondary

Measure	Time frame
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. estimated 14 months.	—

Countries

Denmark

Contacts

Public ContactJeppe Thue Jensen

Herlev Hospital, Gastrounit D, Endoscopy

jeppe.thue.jensen.01@regionh.dk004526136032

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026