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临床试验/NCT00839371
NCT00839371已完成4 期

Bronchoscopy Under Titrated Sedation With Propofol or Midazolam: a Randomized Trial.

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
84
试验地点
1
主要终点
electroencephalographic (BIS) and functional cognitive recovery

研究概览

简要总结

Bronchoscopy is performed on a daily basis for diagnostic and therapeutic purposes. This procedure may cause anxiety and discomfort requiring the use of sedative drugs.

In this study the investigators titrate the administration of sedatives using bispectral analysis of the EEG. The investigators compared 2 drugs, propofol versus midazolam regarding patient subjective tolerance, recovery of brain function, safety and operator's satisfaction.

详细描述

Sedation using anxiolytic, hypnotic and /or analgesic drugs is currently used during flexible bronchoscopy (FB) to facilitate the diagnostic process and improve patient comfort.[The technique of sedation varies widely and depends primarily on the experience of the chest physician. FB can also be done without sedation. However, according to a recent survey, 80% of patients prefer to be sedated during FB and it is also well known that the operator has a tendency to overstate the tolerance of patients during the procedure.

The use of benzodiazepines for sedation undoubtedly enhances the perception and tolerance during FB and they are by far the most widely used drugs because of their ease of administration, their speed of action and the possibility to administer an antidote. The drawback of these sedative agents is related to a high variable individual sensitivity, which can lead to drug overdose and to severe respiratory depression requiring ventilatory assistance. In addition, their sedative and amnesic effects might persist several hours after the procedure.

Over the last decade, major advances in technology and pharmacology have resulted in better cerebral monitoring of anaesthesia with tools like electroencephalographic bispectral index and synthesis of sedative agents of short duration of action as propofol (P).

P is a lipidic emulsion used intravenously for induction and maintenance of anaesthesia. Its effect begins rapidly and ends faster than midazolam (M). The main advantage of P is therefore a faster recovery of mnesic, cognitive and motor functions, whereas M induces anterograde amnesia (1-2 h after bolus) and slower motor reaction . This gives to P a keen interest in ambulatory practice. While P is commonly and safely used in several gastroenterological endoscopic procedures, its use by pneumologist is currently hampered by a lack of expertise and could benefit from collaboration with the anaesthesia team.

This is a randomised trial comparing recovery of brain function and patient subjective tolerance following FB after administration either of P or M for sedation. Patients and operators are blinded to the sedative drug, which is administered and titrated by another chest physician.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for bronchoscopy
  • ASA I to III
  • age between 18 and 79 years
  • capacity of discernment

排除标准

  • visual and psychological problems that might interfere with psychometric testing
  • chronic obstructive pulmonary disease with FEV1 < 50% predicted
  • need for an airway intubation or laryngeal mask insertion
  • fever or other signs of systemic infection
  • hemodynamic instability defined as a resting heart rate (HR) < 60 or ≥ 120 and/or a systolic blood pressure (BP) < 100 or > 180 mmHg
  • significant liver disease and documented soy allergy

研究组 & 干预措施

Midazolam

Active Comparator

i.v. midazolam titration until adequate depth of sedation

干预措施: Midazolam (Drug)

Propofol

Active Comparator

i.v. propofol titration until adequate depth of sedation

干预措施: Propofol (Drug)

结局指标

主要结局

electroencephalographic (BIS) and functional cognitive recovery

时间窗: 24h

次要结局

  • The secondary endpoints are patient subjective tolerance, operator evaluation of patient tolerance and cardiopulmonary adverse events(24h)
  • respiratory depression, hypotension(24h)

研究者

申办方类型
Other

研究点 (1)

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