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Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

NCT03357393 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-01-05

Study results available
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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

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..

Sponsors & Collaborators

  • Lena Nilsson

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-04
Primary Completion
2017-05-09
Completion
2017-05-09

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03357393 on ClinicalTrials.gov