Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence

Study Overview
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Brief Summary
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Introduction: Although inflating tracheal cuff using lidocaine is effective for cough suppression, it may pressure tracheal cuff too much. Intravenous continuous infusion of lidocaine has emerged recently for most general anesthesia in the context of opioid-sparing anesthesia for cancer, but the 95% effective dose (ED95) for cough suppression during anesthesia emergence is not determined yet. Objective: the objectives of this study are to determine the ED95 of continuous infusion lidocaine for suppressing cough reflex during extubation by sex and age group.

Detailed Description
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Ideal patient weight in kg will be considered. Initial dose will be 0.5mg/kg.h and dose-change steps of 0.5mg/kg.h will occur depending on the incidence of emergence cough in the previous patient of the same group: It will increase if coughed in a probability of 95% It will decrease if not coughed in a probability of 5%. It will remain the same otherwise. Maximum dose will be 3mg/kg.h. All patients will receive remifentanil 0.025mcg/kg.min continuous infusion until extubation. Patients groups will be determined by sex and age group (18-60 or >60 years old), therefore, four independent groups will be studied: Female 18 to 60 years old Male 18 to 60 years old Female > 60 years old Male > 60 years old

Official Title
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Intravenous Lidocaine Continuous-infusion to Supress of Cough Reflex During Anesthesia Emergence: Dose-finding Adaptive Trial

Conditions
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Cough

Intervention / Treatment
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* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understands study risks and benefits, signs informed consent. Not pregnant. Not an airway surgery No acute or chronic respiratory disease. Non smoker No chronic cough Exclusion Criteria: Any protocol violation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Interventional Model Description: Four parallel groups will be studied: Female > 60 years old Male > 60 years old Female 18 to 60 years old Male 18 to 60 years old
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Female 18 to 60 years old<br>This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence. | Drug: Lidocaine<br>* Continuous infusion, variable dose of lidocaine.<br>* Other names: Xylocaine;|
| Active Comparator: Male 18 to 60 years old<br>This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence. | Drug: Lidocaine<br>* Continuous infusion, variable dose of lidocaine.<br>* Other names: Xylocaine;|
| Active Comparator: Male > 60 years old<br>This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence. | Drug: Lidocaine<br>* Continuous infusion, variable dose of lidocaine.<br>* Other names: Xylocaine;|
| Active Comparator: Female > 60 years old<br>This adaptive dose-finding group will receive continuous infusion lidocaine using the biased coin method for finding the 95% effective dose (ED95%) for cough suppression. All patients will also receive remifentanil 0.025mcg/kg.h during emergence. | Drug: Lidocaine<br>* Continuous infusion, variable dose of lidocaine.<br>* Other names: Xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough during anesthesia emergence | Dichotomic variable, true if any cough is detected from anesthesia weaning to extubation. | Anytime during anesthesia emergence, before extubation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general anesthesia, cough, anesthesia emergence, lidocaine