Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

Lena Nilsson

Status: Completed

Conditions: Sedation, Bronchoscopy

Treatments: Drug: Midazolam; Drug: Propofol-Lipuro; Drug: Glycopyrrolate; Drug: morphine-scopolamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03357393

BRONSE

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Midazolam and morphine-scopolamine

Active Comparator group

Description:

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

Treatment:

Drug: morphine-scopolamine

Drug: Midazolam

PCS (propofol) with morphine-scopolamine

Experimental group

Description:

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

Treatment:

Drug: Propofol-Lipuro

Drug: morphine-scopolamine

PCS (propofol) with glycopyrronium bromide

Experimental group

Description:

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

Treatment:

Drug: Propofol-Lipuro

Drug: Glycopyrrolate