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临床试验/NCT04769856
NCT04769856已完成不适用

Impact of Non-fasting Strategy on Pre-operative Patients' Anxiety in Cataract Surgery Performed Under Topical Anesthesia

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2021年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
State-Trait Anxiety Inventory (STAI) scale score

研究概览

简要总结

The aim of this prospective study was to investigate whether non-fasting recommendation could reduce preoperative anxiety level, incidence of anesthetist interventions, and number of surgical complications in elective cataract surgery patients.

详细描述

Fear of aspiration makes anesthetists reluctant to challenge standard pre-operative fasting guidelines recommending stopping eating solids and drinking clear fluid 6 hours and 2 hours, respectively before anesthesia. However, hunger and thirst exacerbates patients' anxiety, adversely impacts the patient's comfort and satisfaction, and enhances pain response leading to additional need for analgesia.

Patients undergoing non-invasive procedures requiring no or light sedation may benefit from non-fasting recommendations. The need for preoperative fasting in patients undergoing cataract surgery under topical anesthesia remains controversial. Patients are not fasted before standard cataract surgery under local anesthesia in many cataract centers, in accordance with the UK national guideline published in 2012. However, this practice is not supported by a high level of evidence from prospective clinical trials. So far, the lack of international professional consensus on the matter, local practices are based on institutional recommendations obviating the need for starvation in routine cataract surgery under topical anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Information and collection of patient consent
  • •Age greater than or equal to 18 years
  • •Affiliation to a social insurance
  • •Undergoing cataract surgery under topical anesthesia
  • •Intervention on the 1st eye

排除标准

  • •Refusal to participate
  • •Language barrier incompatible with the performance of a reliable assessment
  • •Behavior disorders
  • •Anesthesia other than topical
  • •Voluntary control disorder
  • •Intervention on the 2nd eye
  • •Taking psychotropic drugs.
  • •Legal protection regime

研究组 & 干预措施

Non-fasting group

Experimental

干预措施: State-Trait Anxiety Inventory (STAI) scale (Other)

Non-fasting group

Experimental

干预措施: Satisfaction scale (Other)

Fasting group

Experimental

干预措施: State-Trait Anxiety Inventory (STAI) scale (Other)

Fasting group

Experimental

干预措施: Satisfaction scale (Other)

结局指标

主要结局

State-Trait Anxiety Inventory (STAI) scale score

时间窗: Baseline (Before surgery)

preoperative anxiety level

次要结局

  • Satisfaction scale score(Immediately after surgery)
  • Incidence of oxygen desaturations(During surgery)
  • Incidence of capsular ruptures(During surgery)
  • Incidence of vitreous outbreaks perceived by the operator(During surgery)
  • Proportion of patients who took their usual antihypertensive therapy(Baseline (Before surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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