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Propofol Target-Controlled Infusion in Emergency Department Sedation

NCT03442803 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-02-22

No results posted yet for this study

Summary

There exists continued controversy over the use of propofol in Emergency Department procedural sedation, this is despite its widespread existence in clinical practice for at least a decade. These concerns are not limited to the ED setting and are primarily related to the pharmacological properties of the drug itself and its potential for harm. The bolus administration of propofol, aimed at a target of sedation, offers several advantages over more traditional agents, yet these advantages are also its limitations. The use of a target-controlled infusion may provide the sedationist with greater control over the pharmacokinetics of propofol and thus reduce the rate of adverse incidents.

This feasibility study aims to use a pragmatic design to test the safety and efficacy of propofol TCI whilst assessing the practicalities of it's use in the ED. If it proves to be feasible then the researchers plan to proceed to a multi centre pilot study to gather information to adequately power a larger randomised multi centre trial.

Conditions

  • Shoulder Dislocation

Interventions

DEVICE

Target-Controlled Infusion

Propofol Target-Controlled Infusion

Sponsors & Collaborators

  • CareFusion

    collaborator INDUSTRY

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Fiona M Burton, MBChB, FRECM · Hairmyres Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United Kingdom

Study Locations

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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 NCT03442803 on ClinicalTrials.gov