Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-04

Study Completion Date

2017-05-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Sedation, Bronchoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

The bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms).

Study Groups

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Midazolam and morphine-scopolamine

Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam is givenas sedation to the Control arm.

morphine-scopolamine

Intervention Type DRUG

Given as premedication for the Control arm and one of the interventions arms.

PCS (propofol) with morphine-scopolamine

Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication

Group Type EXPERIMENTAL

Propofol-Lipuro

Intervention Type DRUG

Propofol is given as sedation to both intervention arms.

morphine-scopolamine

Intervention Type DRUG

Given as premedication for the Control arm and one of the interventions arms.

PCS (propofol) with glycopyrronium bromide

Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.

Group Type EXPERIMENTAL

Propofol-Lipuro

Intervention Type DRUG

Propofol is given as sedation to both intervention arms.

Glycopyrrolate

Intervention Type DRUG

Given as premedication for one of the intervention arms..

Interventions

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Midazolam

Midazolam is givenas sedation to the Control arm.

Intervention Type DRUG

Propofol-Lipuro

Propofol is given as sedation to both intervention arms.

Intervention Type DRUG

morphine-scopolamine

Given as premedication for the Control arm and one of the interventions arms.

Intervention Type DRUG

Glycopyrrolate

Given as premedication for one of the intervention arms..

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patient (≥18 years)
* Planned bronchoscopic procedure with sedation in an outpatient setting
* The patient have after receiving information about the study given his/her signed informed consent to participate.
* Women of childbearing potential only if use of effective contraceptive.

Exclusion Criteria

* Positive pregnancy test S-β-HCG.
* Known/suspected allergy or contraindication\* to any medication within the study.
* Functional disability in both hands which affect the possibility to operate the PCS device.
* Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes