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

INTERVENTION: 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 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Midazolam "Hameln" Product Name: Midazolam "Hameln" Product Code: N05CD08 Pharmaceutical Form: Solution for infusion INN or Proposed INN: MIDAZOLAM CAS Number: 59467‐70‐8 Other descriptive name: Midazolam Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Trade Name: Fentanyl "Hameln" Product Name: Fentanyl "Hameln" Pharmaceutical Form: Solution for infusion INN or Proposed INN: Fentanyl CAS Number: 437‐38‐7 Other descriptive name: FENTANYL Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 50‐ CONDITION: 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 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: To investigate satisfaction with sedation during flexible bronchoscopy. Primary end point(s): Pre‐morbid psyche evaluation; Satisfaction score; Willingness to repeat. Secondary Objective: To study safety of endoscopy nurse administered propofol sedation during flexible bronchoscopy. Timepoint(s) of evaluation of this end point: after inklusion of 128 patients. ; estimated 14 months. SECONDARY OUTCOME: 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. 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