Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Number of Patients With Laryngospasm Postoperatively
研究概览
简要总结
In the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.
The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.
详细描述
During anesthesia practice, one of the common complications of airway management is laryngospasm. The etiology of laryngospasm is unknown but may be due to insufficient depth of anesthesia during tracheal intubation, light plane of anesthesia during tracheal extubation, pain, or presence of airway irritant like laryngoscope blade, irritated volatile agent, suction catheter, surgical debris, mucus, blood, or other foreign body. Laryngospasm occurs in both genders and all ages. Incidence of laryngospasm was reported to the Australian incident monitoring study (AIMS) was 5% with of 22% of them without an attributable cause.
Currently, there is no proven prophylaxis for laryngospasm and the known treatments of laryngospasm are used post-occurrence. However, elimination of factors that lead to laryngospasm is the most indispensable item for reduction of its incidence.
Intravenous (IV) lidocaine interrupts nerve conduction by blocking sodium channels. Recent meta-analysis study showed that IV lidocaine was able to prevent laryngospasm in children. However, in the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.
The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesia score are I or II
- •Undergo for laparoscopic cholecystectomy
排除标准
- •Patient's refusal
- •History of upper respiratory tract infection (URTI) within 2 weeks
- •Persistent type of hyper-reactive airway or asthma
- •History of airway surgery
- •History of gastro-esophageal reflex disease (GERD)
- •Currently receiving sedating or analgesic medication
- •Currently receiving the following medications:
- •Fluvoxamine
- •Erythromycin and Itraconazole
- •β -blocker or Cimetidine
- •History of Lidocaine Allergy
- •History of epilepsy disorder
- •Pregnant or breastfeeding women
- •History of Heavy Smoking ( a smoker with a daily cigarettes consumption of more than 20 pieces
- •History of increased salivation by a disease or medication
- •History of difficult intubation
- •Two or more attempts of intubation
研究组 & 干预措施
Lidocaine
Lidocaine 1% was prepared in 10 mL syringe= 10 mg/mL, dosage was 1mg/kg, one bolus or 10 mL/kg, with range of 2mg could be added or missed. The maximum dose is 100 mg for patients with weight of more than 100
干预措施: Lidocaine (Drug)
Placebo
Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg.
干预措施: Placebo (Other)
结局指标
主要结局
Number of Patients With Laryngospasm Postoperatively
时间窗: within first 15 minutes post-dose
There were 4 scores of laryngospasm: 0 = No Laryngospasm 1. = Stridor or partial laryngospasm 2. = Complete Laryngospasm 3. = Cyanosis
次要结局
未报告次要终点
研究者
Khalid Ibrahim Aljonaieh
Principal Investigator
King Saud University