Lidocaine to Prevent Cough and Hemodynamic Changes in Tracheal Extubation

Study Overview
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Brief Summary
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Coughing during tracheal extubation can be associated to adverse effects like tachycardia, arterial hypertension (AHT), increase of intracranial pressure (ICP) and intraocular pressure (IOP), and the dehiscence of surgical wounds. In ophthalmic, head and neck, and abdominal surgery, and in several other neurosurgical interventions it is vital to prevent these effects. The incidence of laryngeal irritation due to orotracheal intubation hinders patient comfort in the immediate postoperative (POP) period and no pharmacological intervention has been yet proven to prevent it. At the end of the surgical procedure, the depth of the anesthetic plane decreases with the concomitant suspension of the anesthetic agents. However, the patient still requires ventilatory support through the endotracheal tube (EDT). The physical stimulation of the trachea created by this foreign body leads to the activation of the sympathetic nervous system, expressed in AHT, tachycardia, and ICP. To tolerate the EDT and prevent these effects, different maneuvers have been tested such as extubating the patient in a deep anesthetic plane or administering intravenous (IV) narcotics with the entailed complications: airway (AW) obstruction and hypercapnia, and the aspiration of an unprotected AW. Progress has been made with the introduction of ultrashort acting opioids, with significant statistical results. Moreover, beta-blockers, calcium channel blockers, angiotensin converting enzyme inhibitors and dexmedetomidine have been used to decrease the hemodynamic impact associated to tracheal extubation. The use of both IV and intratracheal lidocaine in doses ranging from 1 mg/kg to 3 mg/kg, has been studied with controversial results. In view of the above, and as lidocaine is the most commonly used low-cost drug in all operating rooms with a good safety profile when used at low doses, the purpose of this study is twofold: to assess its effects at reducing coughing and to evaluate its hemodynamic impact when administering IV 1 mg/kg prior to extubation. Then, the efficiency of reducing the incidence of sore throats after the immediate POP shall be investigated.

Official Title
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Efficiency of Intravenous Lidocaine to Reduce Coughing and the Hemodynamic Changes Associated to Tracheal Extubation

Conditions
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Lidocaine

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: American Society of Anesthesiologists Risk I & II. Age 18-65 years. Scheduled for: cholecystectomy, hernioplasty or laparoscopic gynecological surgery, under balanced general anesthesia (GA) and orotracheal intubation (OTI). Exclusion criteria: Local anesthetic (LA) allergy. Presence of predictors of potentially difficult intubation (DI) according to criteria defined by the American Society of Anesthesiologists. Upper airway inflammatory symptoms during the previous week. Chronic kidney disease with clearance lower than 60 ml/m using the Modification of Diet in Renal Disease (MDRD) equation. Child-Pugh B-C liver disease. Treated with ACEinhibitors and/or BB. Second and third grade atrioventricular block. Symptomatic bradycardia. Tachyarrhythmias. Left bundle branch block (LBBB).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: This study was designed as a double-blind randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Group that receives a 1 mg/kg single bolus of 2% IV lidocaine | Drug: Lidocaine<br>* prior to extubation<br>* Other names: GOBBI;|
| Placebo Comparator: Placebo<br>group that receives 0.9% saline solution | Drug: Saline Solution<br>* Prior to extubation<br>* Other names: GOBBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficiency of IV lidocaine in reducing the incidence of coughing | Apply the Minogue scale to assess the coughing associated to tracheal extubation. Modified Minogue scale by Likert: (ordinal, 0 to 5) Grade 1: absence of coughing and muscle stiffness Grade 2: transient coughing while removing EDT Grade 3: moderate cough (3 or less coughing episodes each lasting one or two seconds) Grade 4: muscular stiffness or severe cough (4 ore more episodes lasting more tham two seconds) Grade 5: laryngospasm | From the moment the endotracheal tube is retired to 5 minutes after | 
| Determine the efficiency of IV lidocaine in reducing the arterial hypertension associated with tracheal extubation | Gather mean arterial pressure (MAP) record at the time of the extubation. Difference in MAP between anesthesia ceasing (time 0) and extubation (time 2) (continuous, mmHg) Difference in MAP between time 0 and 5 minutes after extubation (time 3) (continuous, mmHg) | From the end of anesthesia to 5 minutes after tracheal extubation (At time 0, time 2 and time 3) | 
| Determine the efficiency of IV lidocaine in reducing the increase in heart rate (HR) associated with tracheal extubation | Gather HR record at the time of the extubation. Difference in HR between time 0 and time 2 (discreet, bpm) Difference in HR between time 0 and time 3 (discreet, bpm) | From the end of anesthesia to 5 minutes after tracheal extubation (At time 0, time 2 and time 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record the time elapsed from the end of anesthesia and the administration of lidocaine to extubation. | As a safety event. Record time between t0 and t2 (continuous, minutes) | Intraoperative. From the end of anesthesia (time 0) to tracheal extubation (time 2) | 
| Assess immediate POP sore throat | using the Likert ten-point severity pain scale. The scale ranges from 0 to 10. 0 equals no pain, and 10 indicates the worst pain. | 30 minutes after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cough, Sore throat, Hemodynamic changes, Extubation, Lidocaine, Double blind