NCT03357393

Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Lena Nilsson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sedation, Bronchoscopy

Interventions

Type	Name	Description
DRUG	Midazolam	Midazolam is givenas sedation to the Control arm.
DRUG	Propofol-Lipuro	Propofol is given as sedation to both intervention arms.
DRUG	morphine-scopolamine	Given as premedication for the Control arm and one of the interventions arms.
DRUG	Glycopyrrolate	Given as premedication for one of the intervention arms..

Timeline

• Start date: 2016-04-04
• Primary completion: 2017-05-09
• Completion: 2017-05-09
• First posted: 2017-11-29
• Last updated: 2021-01-05
• Results posted: 2021-01-05