The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube

Study Overview
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Brief Summary
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Cough suppression during emergence and tracheal extubation from general anaesthesia has become an important issue as part of patient safety. Cough arised from the mechanical irritation of endotracheal tube and cuff could be accompanied by various adverse effects such as laryngospasm, hypertension, tachycardia, arrhythmia and increase of intracranial, intraocular, or intra-abdominal pressure. Several cough-preventing strategies have been proposed for smooth emergence, such as opioids, dexmedetomidine or lidocaine. Maintenance of remifentanil infusion during emergence has been reported to be an effective method in reducing cough and cardiovascular change without delay of recovery. In previous studies, the effetive effect-site concentraions for 95% of adults (EC95) for preventing cough are a little different depending on anaestheic agent, type of surgery and sex, ranged from 2.14 to 2.94 ng/ml. However, since most of these studies are for sing lumen endotracheal tube, similar preventing effect would not be expected for double lumen tube (DLT) because of its large diameter and long length. Another problem is higher concentration of remifentanil more than 2.5 ng/ml could not guarantee the safety after extubation. The efficacy of a single IV bolus of lidocaine for the prevention of cough has been the subject of numerous trials. Therefore, combined use of lidocaine and remifentanil could effectively prevent emergence cough for DLT without the risk of high concentration of remifentanil.

Official Title
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The Efficacy of Intravenous Lidocaine With Continuous Infusion of Remifentanil for Attenuating Double Lumen Tube Induced Cough During Emergence

Conditions
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Cough, Lidocaine

Intervention / Treatment
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* Drug: Lidocaine Iv
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients needs for double lumen tube intubation for one lung ventilation during surgery with ASA (American society of Anesthesiologists) class I or II Exclusion Criteria: Gastroesophageal reflux disease Obese patients (BMI > 30) Recent upper respiratory infection history (within 3 weeks) Asthma history Anticipating difficult airway

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Remifentanil group<br>Emerge with continuous infusion of remifentanil 1.5 ng/ml | Drug: Remifentanil<br>* Continuous infusion of remifentanil 1.5 ng/ml until extubation<br>|
| Experimental: Lidocaine group<br>Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg | Drug: Lidocaine Iv<br>* Bolus dose of 1.5 mg/kg lidocaine was injected immediate after operation.<br>Drug: Remifentanil<br>* Continuous infusion of remifentanil 1.5 ng/ml until extubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough incidence |  | from the time of end of the operation up to 10 min after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough severity | cough severity is graded as follows; mild cough (1 cough without lifting head), moderate cough ( more than 1 cough not sustained more than 5 seconds), severe cough (cough sustained more than 5 seconds) | from the time of end of the operation up to 10 min after extubation | 
| hoarseness |  | 30 min at the recovery room |