Comparison of Effectiveness Between the Combination of Lidocaine Sprayed at Laryngeal Inlet and on the Cuff of Endotracheal Tube Versus Intravenous Lidocaine for Reducing Cough During Extubation

Study Overview
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Brief Summary
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Coughing during extubation of endotracheal tube (ETT) is a common problem that leads to poor surgical results including hemodynamic change, rebleeding at the surgical wound and wound dehiscence. Recently, lidocaine has been introduced for reducing coughing during extubation. However, data comparing routes of lidocaine application are lacking, thus, this study compared the combination of lidocaine sprayed on laryngeal inlet and cuff of ETT versus intravenous lidocaine injection for efficacy in reducing coughing

Detailed Description
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A prospective randomized control trial was conduct with 164 patients. They were randomly allocated into Gr. A and B. Group A received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation. The same general anesthesia protocol was applied in all of the patients. Incidence and severity of cough during extubation was evaluated. Furthermore, incidence of 24-hour postoperative adverse events (including sore throat, dysphagia, and hoarseness) and hemodynamic response after extubation were analyzed.

Official Title
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Comparison of Effectiveness Between the Combination of Lidocaine Sprayed at Laryngeal Inlet and on the Cuff of Endotracheal Tube Versus Intravenous Lidocaine for Reducing Cough During Extubation: A Prospective Randomized Controlled Trial

Conditions
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Reducing Cough During Extubation

Intervention / Treatment
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* Drug: 10% lidocaine sprayed
* Drug: 2% lidocaine intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who underwent elective surgery with American Society of Anesthesiologists physical status classifications of I and III Exclusion Criteria: patients having body mass index more than 35 kg/m2, high risk of aspiration, chronic smokers more than ten pack-years, chronic cough or recent upper respiratory infection, suspected difficult airway, retained ETT prior surgery, surgery at oral cavity, neck and thoracic region, operative time more than 120 minutes or less than 30 minutes, and history of lidocaine allergy

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomized controled trial was conducted. the investigator allocated patient into two arms. Group A received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the study group (Group A)<br>Patients received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet | Drug: 10% lidocaine sprayed<br>* four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet<br>* Other names: 10% Xylociane;|
| Active Comparator: Comparator group (Group B)<br>Patients received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation | Drug: 2% lidocaine intravenous<br>* 15 mg/kg of 2% lidocaine intravenous injection prior to extubation<br>* Other names: 2% Xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in incidence of coughing | Coughing event was recorded by blinded anesthesiologist | the incidence was recorded during extubation and immediatly extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of coughing | the severity of cough was recorded by blinded anesthesiologist. Coughing level severity (16) was evaluated as 0 = no cough; 1 = slight cough, cough without obvious contraction of abdomen; 2 = moderate cough, strong and sudden contraction of the abdomen lasting less than 5 seconds; 3 = severe cough, strong and sudden contraction of the abdomen sustained more than 5 seconds | the severity was recorded during extubation and immediatly extubation | 
| Incidence of postoperative sore throat | Incidence of postoperative sore throat was recorded by two blinded anesthetist nurses . The numeric rating scale (0 = no, 10 = extreme) was used for evaluation of sore throat. If the numeric rating scale was more than 3, it was considered as a significant adverse event. | the incidence was recorded within 24 hr after extubation | 
| Incidence of dysphonia | Incidence of dysphonia was recorded by two blinded anesthetist nurses . | the incidence was recorded within 24 hr after extubation | 
| Incidence of dysphagia | Incidence of dysphagia was recorded by two blinded anesthetist nurses . | the incidence was recorded within 24 hr after extubation |