Propofol Target-Controlled Infusion in Emergency Department Sedation

NCT03442803 | Unknown

• 1 other identifier: GN16AE183
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

sedation; Emergency Department; Target Controlled infusion; propofol

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Patient satisfaction score using a VAS with the question, "How satisfied were you with the procedure? Please mark on the line below with a vertical mark." The scale ranges from not satisfied to very satisfied.

  Patient satisfaction will be assessed when patient is fully awake, this will be recorded on one single occasion, on average 30minutes after the procedure.

Secondary Outcomes (4)

• Nursing Opinion of the Patient Experience

  Immediately after procedure

• Incidence and severity of adverse events per World Society of Intravenous Anaesthesia adverse event reporting tool

  Duration of sedation, on average 40 minutes

• Time from commencement of sedation to fit for discharge as per Royal College of Emergency Medicine guidelines outlining fit for discharge.

  End of the patient's Emergency Department attendance post procedure and prior to discharge, on average 3 hours.

• % of patients recruited vs % of patients approached

  At the point in their attendance when approached for consent to be recruited, on average 30 minutes into their attendance.

Study Arms (1)

Propofol TCI

EXPERIMENTAL

Delivery of Propofol via a Target-controlled infusion pump for procedural sedation.

Device: Target-Controlled Infusion

Interventions

Target-Controlled Infusion DEVICE

Propofol Target-Controlled Infusion

Propofol TCI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years
• Clinical and/or radiological evidence of acute anterior shoulder dislocation
• ASA I or II
• Fasted ≥ 90mins2,3,27,28
• Weight ≥50kg

You may not qualify if:

• Inability to provide or refusal of informed consent
• Previous attempt at reduction during the same presentation
• Previously enrolled in the study
• Clinical and/or radiological evidence of acute posterior shoulder dislocation
• Clinical and/or radiological evidence of concomitant ipsilateral upper limb fracture (with the exception of an isolated avulsion fracture of the greater tuberosity or a fracture of the glenoid labrum)
• Concomitant multi-system injury
• History of difficult intubation/airway surgery
• ASA grade III, IV or V
• Haemodynamic instability
• Pregnancy
• Contraindication to sedation
• Allergy to study drugs or eggs
• Clinician decision
• Morphine administration within the preceding 20minutes prior to starting TCI (can be included if \>20minutes)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• C. R. Bard: collaborator

Study Sites (4)

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

RECRUITING

Hairmyres Hospital

Glasgow, G75 8RG, United Kingdom

RECRUITING

Royal Alexandra Hospital

Paisley, PA2 9PN, United Kingdom

RECRUITING

Related Publications (2)

• Burton FM, Lowe DJ, Millar J, Corfield AR, Watson MJ, Sim MAB. Propofol Target-Controlled Infusion in Emergency Department Sedation (ProTEDS): a multicentre, single-arm feasibility study. Emerg Med J. 2021 Mar;38(3):205-210. doi: 10.1136/emermed-2020-209686. Epub 2020 Dec 9.

  PMID: 33298604 DERIVED

• Burton FM, Lowe DJ, Millar J, Corfield AR, Sim MAB. A study protocol for a feasibility study: Propofol Target-Controlled Infusion in Emergency Department Sedation (ProTEDS)-a multi-centre feasibility study protocol. Pilot Feasibility Stud. 2019 Feb 18;5:27. doi: 10.1186/s40814-019-0412-y. eCollection 2019.

  PMID: 30820338 DERIVED

MeSH Terms

Conditions

Shoulder Dislocation; Emergencies

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fiona M Burton, MBChB, FRECM

  Hairmyres Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona M Burton, MBChB, FRCEM

CONTACT

+44 1355 584103; fionaburton@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 22, 2018
• Study Start: April 3, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)