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临床试验/NCT03603873
NCT03603873已完成不适用

Preoperative Anxiety Level, Premeds and General Anaesthetic Proceedings

CHU de Reims1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2017年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
1,200
试验地点
1
主要终点
Preoperative anxiety level

研究概览

简要总结

Although it seems obvious that the high level of preoperative anxiety may affect intraoperative anaesthetic requirements and recovery adversely, there are several contradictory studies about this subject. Furthermore, the effects of anxiolytic premedication are actually disputed: sedative premedication is widely administered but little clinical evidence supports its use.

We want to evaluate the effects of pre-procedure anxiety for propofol needs in patients receiving general anaesthetic procedure. We also want to know if premedication is useful according to the preoperative anxiety level, in order to determine if a sub-group of patients benefit from it.

详细描述

This study will be carried out in solely at the institute of CHU de Reims, France (Reims Teaching Hospital) from March 2017 to May 2017. Selected patients will be over the age of 18, among those receiving general anaesthesia for surgery. Demographic data and medical history will be collected after written consent. Before the anaesthetic procedure, an APAIS questionnaire (Anxiety evaluation form) will be filled out by each patient.

The medical, anaesthetic and surgical care will not be changed. In the operating room, we will proceed with anaesthetic induction following a medical protocol according to the practice of our hospital (TCI Target Controlled Infusion or manual induction): the propofol infusion or injection is started with an initial effect-site concentration or dose and increased step by step until patients present the clinical en points defined as LOC (loss of consciousness, i.e. no response to a verbal command).

The effect-site concentration of propofol, induction time required for a loss of consciousness (LOC), and preoperative incidents will be recorded by an anaesthetist student nurse and will be recorded in a data book.

After surgery, we will record any secondary effect attributable to premedication.

The day after surgery, patients will be assessed with the EVAN-G questionnaire. Statistical analysis will be done in sub-groups with variance analysis. We will also do multivariate regression analysis according to the type of premedication, demographic data, preoperative variable and preoperative anxiety level. If the number of included patients allows it, we will do propensity score matching for premedication.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • age > 18 years old
  • surgery with general anaesthetic, programmed, in emergency or ambulatory
  • Cognitive level adequate to submit APAIS - EVANG form
  • General anaesthetic induction procedure using propofol

排除标准

  • ASA 4 level
  • Patient refusal
  • pregnancy
  • Rapid Sequence Induction (ISR)
  • General Anaesthetic induction procedure using another drug than propofol (thiopental - etomidate)

结局指标

主要结局

Preoperative anxiety level

时间窗: Day 0

this outcome will be interpreted according to the preoperative anxiety level (APAIS score)

Premeds

时间窗: Day 0

this outcome will be interpreted according to the use or not of premeds

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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