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临床试验/NCT04816344
NCT04816344已完成不适用

The Frequency of Emergence Delirium in Children Undergoing Outpatient Anaesthesia for Magnetic Resonance Imaging

Turkiye Yuksek Ihtisas Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年7月1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
入组人数
140
试验地点
1
主要终点
emergence delirium

研究概览

简要总结

Sedation or anaesthesia is necessary to be able to perform magnetic resonance imaging (MRI) on children who cannot keep still or are uncooperative, and thus the targets of maximum patient safety, successful imaging, and the highest imaging quality can be achieved. There are various drugs for sedation in MRI. A child with Anaesthesia Emergence Delirium (AED) has a state of consciousness which can be described as "irritable, uncompromising, inconsistent, crying inconsistently, wailing, and kicking". The incidence of AED worldwide has been reported to vary between 18% and 80%, depending on the diagnostic criteria used. This difference can usually be explained by the use of different scales and defining criteria. In 2004, Sikich and Lerman developed the Paediatric Anaesthesia Emergence Delirium (PAED) scale, including cognitive evaluation components in addition to agitation behaviours, and the validity and reliability of this scale have been proven. In a study of anaesthesia early delirium in children by Bong et al.7 a score of ≥10 on the PAED scale was shown to have the greatest sensitivity and specificity for the diagnosis of anaesthesia early delirium.

The aim of this study was to investigate the effect on the occurrence of emergence delirium, and recovery, of propofol and ketofol in paediatric patients undergoing diagnostic MRI following premedication with intranasal dexmedetomidine and midazolam.

详细描述

This was a prospective, observational, and single-center study conducted between July-November 2018. The study protocol was approved by the Local Ethics Committee. The study was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from the parent.

The patients were separated into four groups according to the anaesthetic agents given.Intranasal premedication was applied to all the patients, then an intravenous cannula was placed and the anaesthetic agents were administered intravenously. The Ramsay Sedation Scale (RSS) was used to evaluate the level of sedation, with a target of 5 points. The RSS is scored from 1-6 as follows: 1: the patient is worried and anxious, or restless, 2: the patient is calm and co-operative, and can be directed, 3: the patient only responds to instructions, 4: the patient responds rapidly to painful stimuli, 5: the patient demonstrates a slow response to painful stimuli, 6: the patient does not respond. When RSS 5 was reached following the first bolus dose of the drug, an additional dose was administered. When RSS 5 was obtained and hemodynamic stability was ensured, the patient was placed on the MRI table.

The patient was monitored in the recovery room for regaining consciousness for up to 30 mins after the procedure. AED was evaluated using the PAED scale by a nurse trained in the use of this scale. PAED scoring was repeated every 5 mins until the patient was discharged from the recovery room. If the PAED score was ≥10, a diagnosis of AED was made. Adverse events such as laryngospasm, desaturation (SpO2 <95%), respiratory depression, bradycardia, allergy, hiccoughs, nystagmus, nausea, and vomiting were recorded. When a Modified Aldrete Score of >9 was obtained, the child was observed for a further 15 mins then transferred from the recovery room.

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
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged between 2 and 10 years,
  • undergoing outpatient anaesthesia for elective MRI under sedation,
  • classified as American Society of Anesthesiologists (ASA) grade I-II.

排除标准

  • difficult airway,
  • allergies to the study drugs,
  • severe central nervous system disease (eg, brain tumour, uncontrolled seizures),
  • mental motor retardation,
  • the application of another procedure after MRI sedation,
  • whose parents declined to participate in the study.

结局指标

主要结局

emergence delirium

时间窗: until 30 minutes after arrival in the recovery room

the incidence of emergence delirium

次要结局

  • adverse events(up to 1 hour after anesthesia)

研究者

发起方
Turkiye Yuksek Ihtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Derya Karasu, MD

Assoc Prof.

Bursa Yüksek İhtisas Education and Research Hospital

研究点 (1)

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