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临床试验/NCT05601674
NCT05601674已完成不适用

The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty: A Randomized, Controlled Trial

Inonu University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
Richmond Agitation-Sedation Scale (RASS)

研究概览

简要总结

Emergence agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia; this may cause respiratory depression, nausea and vomiting, as well as an increase in blood pressure, heart rate and myocardial oxygen consumption. Although its pathogenesis remains unclear, ENT (ear, nose and throat) surgical procedures have been reported to have a higher incidence of agitation in both adults and children. In recent years, low-flow inhalation anesthesia has been widely used in adult anesthesia practice. The aim of this study is to compare the effects of low flow anesthesia and normal flow anesthesia on emergence agitation.

详细描述

Emergence agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia; this may cause respiratory depression, nausea and vomiting, as well as an increase in blood pressure, heart rate and myocardial oxygen consumption. Hypoxia can lead to serious complications such as aspiration pneumonia, bleeding or reoperation. Although its pathogenesis remains unclear, ENT (ear, nose and throat) surgical procedures have been reported to have a higher incidence of agitation in both adults and children.

In recent years, low-flow inhalation anesthesia has been widely used in adult anesthesia practice. Low flow anesthesia has many advantages; the consumption of inhalation agents is reduced, the temperature and humidity of the airways are maintained, the cost of anesthesia and pollution caused by atmospheric waste gases are reduced. In addition, because the temperature and humidity of the tracheobronchial tree are preserved, respiratory functions and mucociliary activities are better preserved. In low-flow anesthesia, the concentration of inhaled anesthetics changes very slowly, and their concentration gradually decreases after the administration is terminated. Since the anesthetic concentration will slowly decrease in the low-flow group during termination of anesthesia, the concentration difference between the brain and lungs will be small. In addition, it is known that a longer period between discontinuation of the administration of anesthetic agents and extubation reduces emergence agitation. This seems possible with the low-flow anesthesia technique.

The aim of this study is to compare the effects of low flow anesthesia and normal flow anesthesia on emergence agitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-50 years
  • ASA class I-II,
  • scheduled for elective rhinoplasty surgery under general anesthesia

排除标准

  • history of allergy to nonsteroidal anti-inflammatory drugs,
  • bleeding diathesis or anticoagulant use,
  • psychiatric drug use,
  • previous rhinoplasty surgery
  • patient refusal

结局指标

主要结局

Richmond Agitation-Sedation Scale (RASS)

时间窗: From extubation to 30 minutes of arrival in the postoperative care unit

Sedation and agitation will be assessed immediately after extubation with the Richmond Agitation-Sedation Scale. RASS is divided into 10 levels (score range, -5 to 4, higher scores indicate more agitation)

次要结局

  • Surgeon satisfaction(immediate postoperative period)
  • Ramsey Sedation Scale (RSS)(From extubation to 30 minutes of arrival in the postoperative care unit)
  • Boezaart score(immediate postoperative period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ülkü Özgül

Professor

Inonu University

研究点 (2)

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