The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Intravenous Lidocaine on the Incidence of Post-extubation Laryngospasm: A Randomised Controlled Trial

Conditions
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Laryngospasm

Intervention / Treatment
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* Drug: Lidocaine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesia score are I or II Undergo for laparoscopic cholecystectomy Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>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 | Drug: Lidocaine<br>* 1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued.<br>* Other names: Xylocaine;|
| Placebo Comparator: Placebo<br>Normal saline was prepared in 10 mL syringe, dosage was 1 mL/10 kg. | Other: Placebo<br>* 1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Laryngospasm Postoperatively | There were 4 scores of laryngospasm: 0 = No Laryngospasm = Stridor or partial laryngospasm = Complete Laryngospasm = Cyanosis | within first 15 minutes post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngospasm, Lidocaine