drugset / Trial / NCT02226328

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

NCT02226328 ↗

Phase 4 Unknown 128 enrolled Copenhagen University Hospital at Herlev
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2014-11
Primary completion
2015-12
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 0.025 mg —
Comparator Fentanyl Other / unclassified 0.05 mg —
Comparator Midazolam Small molecule 1 mg —
Subject Propofol Small molecule 10 mg —
Subject Propofol Small molecule 20 mg —

Indications

No indication recorded.