Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

Study Overview
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Brief Summary
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The purpose of the study is to determined whether the administration of alkalized 4% lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous oxide as an anesthetic agent.

Detailed Description
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The diffusion of nitrous oxide inside the endotracheal cuff leads to increase pressure, pain and coughing. Studies have shown benefit of alkalized lidocaine and other mediums within the cuff with nitrous oxide. No study has yet evaluated the benefit of alkalized lidocaine in long surgeries without the use of nitrous oxide.

Official Title
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Evaluation of the Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation in Surgeries Without Nitrous Oxide Lasting More Than 2 Hours

Conditions
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Coughing, Extubation, Lidocaine, Endotracheal Cuff

Intervention / Treatment
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* Procedure: Endotracheal intubation with injection of liquid in the cuff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - ASA 1,2 or 3 patients requiring general anesthesia for an elective urological or gynecological surgery predicted to last more than 2 hours Exclusion Criteria: Patient refusal Lidocaine allergy Any allergies to drugs or anesthetics used during the study Under 18 years of age Pregnant Previous airway surgery Cormack 3 or 4 or anticipated difficult airway Upper respiratory tract infection in the last month Active respiratory disease Chronic cough or throat pain Gastro-esophageal reflux disease or at risk for aspiration

Ages Eligible for Study
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Minimum Age: 18 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: Alkalized lidocaine<br>160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal. | Procedure: Endotracheal intubation with injection of liquid in the cuff<br> <br> |
| Placebo Comparator: Sterile saline<br>4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal. | Procedure: Endotracheal intubation with injection of liquid in the cuff<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coughing |  | 24 hours after the end ofsurgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Throat pain |  | 24 hours after the end of surgery | 
| Nausea and Vomiting |  | 24 hours after end of surgery | 
| Hoarseness of the voice |  | 24 hours after end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impact of alkalized lidocaine on coughing at extubation