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临床试验/NCT03197753
NCT03197753已完成不适用

Postoperative Discomfort and Emergence Delirium In Children Receiving Dental Treatment Under General Anesthesia: Comparison Of Nasal Tracheal Intubation and Laryngeal Mask Airway

Aydin Adnan Menderes University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年6月15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
发起方
入组人数
70
试验地点
1
主要终点
Postoperative discomfort

研究概览

简要总结

The aim of this prospective, randomised, controlled clinical trial was to compare immediate postoperative discomfort, emergence delirium and recovery time of the patients intubated using either laryngeal mask airway or nasotracheal intubation.

详细描述

A total of 70 children aged 3 to 7 years received full mouth dental rehabilitation under general anesthesia. Children were randomly grouped into Laryngeal mask airway (LMA) group (n=35) and nasotracheal intubation (NTI) groups (n=35). In LMA group LMA was inserted after anesthesia induction using 8% sevoflurane. In NTI group rocuronium and remifentanil were given intravenously during %8 sevoflurane induction and the patients were intubated by a nasotracheal tube. After completion of the dental treatments patients were transferred to the post anesthesia care unit (PACU). Duration of dental operation ,duration of anesthesia, recovery time, postoperative discomfort, emergence delirium, pediatric dentist's access were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor

入排标准

年龄范围
3 Years 至 7 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Aged 3-7 years,
  • •ASA I and II
  • •Lack of chairside cooperation for dental treatment in clinical setting.

排除标准

  • •A history of of anticipated difficult entubation ,
  • •Patient with pharyngeal pathology patients with known pulmonory or cardiovascular disease,
  • •When the expected dental procedure was more than two hours
  • •Mental retardation and those whose parents did not consent to their participation in the study.

研究组 & 干预措施

Laryngeal mask airway

Experimental

Laryngeal mask airway insertion

干预措施: Laryngeal mask airway (Device)

Nasotracheal intubation

Active Comparator

Nasotracheal tube insertion

干预措施: Nasotracheal intubation (Device)

结局指标

主要结局

Postoperative discomfort

时间窗: Postoperative 1 hour

Sore throat

次要结局

未报告次要终点

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SULTAN KELES

Assist. Prof.Dr.

Aydin Adnan Menderes University

研究点 (1)

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