跳至主要内容
临床试验/NCT03442803
NCT03442803Unknown不适用

Propofol Target-controlled Infusion Versus Usual Care for the Sedation of Adult Patients With Acute Shoulder Dislocation in the Emergency Department

NHS Greater Glasgow and Clyde4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
4
主要终点
Patient satisfaction

研究概览

简要总结

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.

详细描述

Procedural sedation and analgesia (PSA) has long been a core skill of the Emergency Physician, although over the last decade, developments in patient monitoring and the use of newer sedative and analgesic agents have served to improve both safety and efficacy. Despite these advances and their consolidation into well-designed guidelines concern regarding the safety of ED PSA persists.

More specifically, concerns have been raised regarding the use of propofol, an ultra-short acting anaesthetic agent. The practice of using sub-anaesthetic doses of propofol to achieve sedation in ED PSA originated around the turn of the millennium and has since become the most common choice of sedative in the ED. Propofol offers a number of advantages as a sedative agent, including; a short onset and recovery time, amnesiac properties and good efficacy. The cost of these properties is in part, a narrow therapeutic range.

When given as a bolus, propofol will induce a spectrum of states up to and including general anaesthesia, dependent on the dosage. The correlation between dose and effect varies based on several patient factors. Whilst targeting a state of sedation it is possible for the operator to 'overshoot' moving rapidly from Conscious Sedation to Deep Sedation to General Anaesthesia. The inadvertent induction of general anesthesia may result in unanticipated complication.

The principle complications associated with accidental over-sedation or general anesthesia relate to the patency of the patient's airway. The reported frequency of airway complications during ED PSA with propofol range from 5.0% to 9.4%7, this includes a rate of supplemental ventilation of between 3.0% and 9.4%, with oxygen desaturation occurring in between 5% and 7% of cases12. In addition, the bolus administration of propofol may result in transient hypotension. Despite being a relatively short lived effect, this may be pronounced in those with intravascular volume depletion or in the elderly, and in some may be profound, with one series demonstrating that 3.5% of those undergoing PSA with propofol experience ≥ 20% falls in blood pressure. At first inspection the reported rate of complication may appear low, and has by some been interpreted as evidence of the relative safety of ED PSA, however alternative views have been expressed in the context of much lower rates of adverse events seen in elective painful procedures requiring conscious sedation. This is compounded by the non-standard way in which adverse events have been reported across studies.

A potential solution to the adverse events experienced with the bolus administration of propofol is the use of a target-controlled infusion (TCI). This method is widely used in anaesthetic practice and whilst the PK remains the same irrespective of if you give a bolus or infusion of propofol, TCI allows the titration in perhaps a more controlled manner.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

Propofol TCI

Experimental

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

干预措施: Target-Controlled Infusion (Device)

结局指标

主要结局

Patient satisfaction

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

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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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