The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

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

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.

Study Overview

• Status: Terminated
• Conditions: Laryngospasm
• Intervention / Treatment: Drug: Lidocaine; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11472
    • College of Medicine - King Saud University Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: Khalid I Aljonaieh, Lecturer, King Saud University

Publications and helpful links

Helpful Links

• King Saud University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 3, 2011
• First Posted (Estimate): October 4, 2011

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: April 9, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Lidocaine; Laryngospasm
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Laryngeal Diseases; Vocal Cord Dysfunction; Laryngismus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: E-11-491