The Effects of Dexmedetomidine on Induction of Anaesthesia and Onset of Neuromuscular Blockade in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Onset of neuromuscular blockade
研究概览
简要总结
The effects of dexmedetomidine on the onset of both the general anaesthesia induction and the neuromuscular blockade in children of school age will be investigated. Ten minutes before the induction of general anaesthesia, the first group will receive continuous infusion of dexmedetomidine (DEX group), while the second group will receive normal saline (Placebo group).
详细描述
Children 4 to 12 years old, ASA I-II, scheduled for elective minor or medium procedure under general anaesthesia will be included in the study, after written informed concern from their parents has been obtained. Participants will be randomly allocated according to the type of the solution infused 10 minutes before the induction of general anaesthesia into one of the following two groups using the closed envelop method.
DEX group: patients will receive 0.5μcg/kg IV bolus of dexmedetomidine in 10 min, right before the induction of general anaesthesia. The concentration of dexmedetomidine solution is 0.2μcg/ml, (100μcg of dexmedetomidine are diluted in 50ml N/S 0.9%), which corresponds to volume (ml) calculated by the type: "body weight (Kg)/4 or body weight (Kg) X 0.25".
Placebo group: patients will receive N/S 0.9% IV in 10 min, right before the induction of general anaesthesia. The volume infused (ml) is determined by the same type: "body weight (Kg)/4 or body weight (Kg) X 0.25".
The above solutions will be prepared by the anaesthetist who will provide the anaesthesia and will not be known to the anaesthetist who will record the study's measurements.
No premedication will be given. All children will receive the same anaesthesia induction scheme.
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
- Single (Outcomes Assessor)
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children underoing elective surgery under general anaesthsia
- •age 4-12 years old
排除标准
- •patient or parent refusal
- •Mallampati score> 3
- •severe systemic cardiac disease
- •neuromuscular disease
- •recent respiratory infection
- •drug allergy
研究组 & 干预措施
Dexmedetomidine
Drug: dexmedetomidine (Dexmed) solution(100μcg of dexmedetomidine in 50ml N/S 0.9%). given at a bolus dose of 0.5μcg/kg of the dexmedetomidine solution [that corresponds to the volume (ml) calculated by the type "body weight (Kg)/4 or body weight (Kg) X 0.25".
THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY
干预措施: Dexmedetomidine (Drug)
0.9 % saline
Drug:0.9 % saline solution (Normal saline) given at a volume (ml) determined by the type: "body weight (Kg)/4 or body weight (Kg) X 0.25" THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY
干预措施: 0.9% saline (Other)
结局指标
主要结局
Onset of neuromuscular blockade
时间窗: Up to 5 minutes after the injection of rocuronium
Neuromuscular blockade is estimated with TOF acceleromyography, while onset of neuromuscular blockaded is defined as the time needed to achieve TOF=0 after the injection of rocuronium.
次要结局
- Number of participants who developed bradycardia(Up to 30 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively)
- Number of participants who developed hypotension(Up to 30 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively)
- Onset of anaesthesia induction(Up to 15 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively)
研究者
Paraskevi Matsota
Assoc Prof of Anaesthesiology
Attikon Hospital