Comparative Effect of Neuromuscular Blockade Reversal Agent on Extubation Conditions, Postoperative Cognitive Function and Behaviour of School-aged Children Undergoing Ear Note Throat (ENT) Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- time of achieving extubation
研究概览
简要总结
The aim of this prospective randomized study is to investigate comparatively the effect of neostigmine-atropine versus sugammadex on speed and quality of recovery and on postoperative cognitive function & behavior in children undergoing ENT surgery under general anaesthesia.
详细描述
The aim of this prospective randomized study is to investigate comparatively the effect of neostigmine-atropine vs sugammadex on time of achieving extubation, quality of recovery, postoperative cognitive function and behaviour of children undergoing ENT surgery under general anaesthesia.
In this study after parental approval has been obtained, children with age 6-12 yrs undergoing tonsillectomy and/or adenoidectomy under general anaesthesia will be included. General anaesthesia will be performed using Total Intravenous Anaesthesia (TIVA) technique with continuous infusion of propofol and remifentanil. Rocuronium will be used to achieve neuromuscular blockade (NMB). Neuromuscular reversal will be performed using either atropine-neostigmine or sugammadex. Patients will be divided into 2 groups according to the type of NMB reversal agent used. Intraoperative monitoring will include Bispectral Index Sedation (BIS), SpO2, capnography, noninvasive measurements of blood pressure, heart rate and train of four (TOF).
Children will be assessed preoperatively (one day before surgery and at the morning of day of surgery), intraoperatively, immediate postoperatively and will be followed up for 15 postoperative days. Additionally, parents will be cooperated and questioned.
The primary end-points of the study include the comparative investigation of the effect of neostigmine-atropine vs sugammadex on time of achieving extubation, quality of recovery, and postoperative cognitive function of children. Secondary endpoints will include side effects, signs of residual neuromuscular blockade, agitation and postoperative behavioural changes of children.
For this purpose the following scales and questionnaires will be used:
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
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children undergoing ENT surgery under general anaesthesia.
排除标准
- •Parents refusal
- •Cognitive impairment
- •Difficulty in communication due to language issues
- •Psychiatric disorder
- •Severe systematic disorder
- •Known allergy to any drug used
研究组 & 干预措施
sugammadex
iv sugammadex 2 mg/Kg
干预措施: Sugammadex (Drug)
neostigmine - atropine
iv neostigmine 0,05 mg/Kg - atropine 0,02 mg/kg
Efficacy, safety and effect on cognitive and behavioural function
干预措施: neostigmine - atropine (Drug)
结局指标
主要结局
time of achieving extubation
时间窗: 10 min
time of achieving extubation
次要结局
- Behavioural function(up to 15th postoperative day)
- signs of residual neuromuscular blockade(1 hour)
研究者
Paraskevi Matsota
Associate Professor of Anaesthesiology
Attikon Hospital