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临床试验/NCT00355693
NCT00355693Unknown4 期

Effect Site Controlled, Reaction Time Safeguarded, Patient Maintained Sedation With Propofol A) in Oral Surgery Patients B) in General Dentistry Patients C) in Colonoscopy Patients

University of Glasgow2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年10月1日最近更新:
适应症

试验速览

阶段
4 期
入组人数
60
试验地点
2
主要终点
Minimal Sedation Level obtained (modified Objective Observers's Assessment of Sedation)

研究概览

简要总结

Whether patient-maintained sedation (the patient controls his/her degree of sedation using a hand-held device) using the drug propofol is safer and more effective when using deteriorating reaction time as an added safeguard against the potential for over sedation in a groups of patients undergoing oral surgery, general dentistry and colonoscopy.

详细描述

Patients receiving conscious sedation for dentistry and endoscopy are usually treated with intermittent bolus doses of intravenous midazolam (administered by the operator-sedationist). The safety of such a regime has been questioned with reports of up to 13 % of patients desaturating to below 80 % in the recovery area following sedation for endoscopy. Mortality occurs in 0.05 % of endoscopy patients (with approximately 60 % of this being due to hypoxaemia). The aim of our work, therefore, is to look at providing sedation that is both safer as well as being efficacious.

The drug propofol, the agent most commonly used to induce general anaesthesia in the UK, is also frequently administered intravenously by anaesthetists in low doses to provide conscious sedation for patients undergoing unpleasant procedures i.e. patients become relaxed, anxiety-free, but maintain verbal contact throughout.

The technique of patient maintained sedation using the drug propofol (the patient can increase the amount of sedation (and propofol) they receive by pressing a demand button attached to a standard infusion device) has been used by anaesthetists and evaluated since 1997.

Several recent studies published and submitted for publication by this research group on patient maintained sedation using the drug propofol have shown this method of sedation to be safe and effective in dental patients (over 120 patients studied). It was also shown that this method, when compared to the established method of sedation in oral surgery (the dentist administering doses of midazolam intravenously), to produce both quicker recovery and less anxiety prior to the surgery.

The routine use of propofol traditionally is restricted to anaesthetists, as in high doses general anaesthesia is produced with possible loss of airway patency. Currently the safety feature is predominantly that as patients become more sedated they cannot press the patient demand button and hence cannot increase the amount of propofol they are receiving. Also the device ensures that the blood and brain concentrations have equilibrated to within 10% of each other before another successful demand for propofol can be made (usually takes approximately two minutes) and it only allows a maximum calculated brain concentration of 3 micrograms/milliliter of propofol. The device also will start to decrease the calculated brain concentration of propofol if the demand button has not been pressed for six minutes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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
否

入选标准

  • •ASA I or II (healthy or mild systemic illness) undergoing planned dental surgery or colonoscopy.
  • •Age 18 - 65

排除标准

  • •ASA III or above
  • •Out with age group above
  • •Contraindication to propofol
  • •History of epilepsy
  • •History of substance abuse
  • •Major Psychiatric illness
  • •Pregnancy or breastfeeding
  • •Unable or unwilling to give informed consent
  • •Unable to use necessary apparatus
  • •Vulnerable groups

结局指标

主要结局

Minimal Sedation Level obtained (modified Objective Observers's Assessment of Sedation)

(Scores 5, fully awake to 1, unresponsive)

Maximal change in oxygen saturation (SpO2)

次要结局

  • Effect site concentrations of propofol
  • Anxiety Levels
  • Requirement for supplementary oxygen (if SpO2 < 90%)
  • Requirement for airway support
  • Maximal change in heart rate (HR) and blood pressure (BP)
  • Operator assessment (ease of procedure, cooperation)
  • Patient Satisfaction and recollection

研究者

申办方类型
Other

研究点 (2)

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