Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy
Status:
Completed
Trial end date:
2017-05-09
Target enrollment:
Participant gender:
Summary
bronchoscopy - a randomized controlled trial" (EudraCT number: 2015-005274-38, protocol
number: "BRONSE") is a phase IV single centre prospective randomized controlled trial with
parallel groups. A total of 150 adult outpatients undergo diagnostic bronchoscopy during
sedation and are randomized into three sedation arms (1:1:1); sedation with midazolam and
morphine-scopolamine as premedication (clinical routine), sedation with propofol using PCS
and morphine-scopolamine as premedication, and sedation with propofol using PCS and
glycopyrronium bromide as premedication. The study is partially blinded, the bronchoscopist
is blinded regarding given premedication for patients given PCS (two sedation arms). The
hypothesis is that PCS increase the amount of patients ready for discharge, and further that
patient characteristics affect the amount of propofol administered. The endpoints are
primarily the amount of patients ready for discharge within 2 hours and secondary assessment
of patient recovery and satisfaction as well as bronchoscopist evaluation and doses of
administrated drugs. Finally safety variables are collected such as vital signs and
interventions performed to maintain cardiovascular and respiratory stability.