Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia: Interventional Controlled Randomized Double Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Incidence of Perioperative Respiratory Complications
研究概览
简要总结
The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:
- Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?
- What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 to 14 years.
- •American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
- •Scheduled or urgent surgery or radiological exploration under general anesthesia.
- •Upper respiratory tract infection (URTI) symptoms present for less than 15 days.
排除标准
- •Refusal of participation by parents.
- •Children on long-term corticosteroid or bronchodilator therapy.
- •Contraindications to the use of lidocaine or other drugs used in the protocol.
- •Patients who did not adhere to the study protocol.
研究组 & 干预措施
Group L: IV Lidocaine Group
Participants in this group will receive a volume of weight*0.15 ml intravenous (IV) lidocaine at a dose of 1.5 mg/kg diluted to 10 mg/mL, administered at the induction of anesthesia..
干预措施: Lidocaine (drug) (Drug)
Group P: Placebo Group
Participants in this group will receive an intravenous placebo (normal saline solution), equivalent in volume (weight*0.15 ml) to the lidocaine group, administered at the induction of anesthesia.
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
结局指标
主要结局
Incidence of Perioperative Respiratory Complications
时间窗: Within the first 2 hours post-operation.
Measure the occurrence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation, bronchospasm) from the induction of anesthesia until discharge from the recovery room.
次要结局
- Incidence of Side Effects Related to IV Lidocaine(Within the first 24 hours post-operation.)
研究者
Mehdi Trifa
MD
Tunis University