Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients

Study Overview
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Brief Summary
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The goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. The main questions it aims to answer are: Cough incidence on both groups Which method is preferable to reduce post-extubation cough incidence

Official Title
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Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients

Conditions
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Cough

Intervention / Treatment
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* Drug: Lidocaine IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA class 1 and 2 Thyroidectomy patients in Hasan Sadikin Bandung Hospital Exclusion Criteria: Subjects' refusal Had history of drug allergy, specifically lidaocaine Had history of asthma or other lung diseases Active smoker History of arrhythmia Bradycardia subjects (<60 beats per minute) Pregnant people Perioperative upper respiratory tract infusion Routinely consume ACE inhibitor / bronchodilators / steroid Renal dysfunction Liver dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Comparison
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Lidocaine Intravenous Infusion<br>Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by continuous intravenous administration of 1.5 mg/kgBW/hour lidocaine until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using a syringe pump. Continuous administration of lidocaine was prepared by the research team as 10 cc of 20 mg/cc lidocaine in a 10 cc syringe and 10 cc of 0.9% NaCl in a 10 cc syringe. | Drug: Lidocaine IV<br>* Lidocaine given as bolus or continuous infusion.<br>|
| Active Comparator: Bolus Lidocaine Intravenous<br>Patients were given a loading dose of 1.5 mg/kgBW intravenous lidocaine for 10 minutes before induction of anesthesia using a syringe pump, followed by intravenous infusion of saline with the same volume until 30 minutes before the end of the surgery (when the skin is being sutured by the surgeon) using syringe pump. | Drug: Lidocaine IV<br>* Lidocaine given as bolus or continuous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Extubation Cough Grade | Cough graded according to the following criteria: Grade 0: no cough; Grade 1: mild, only 1 cough; Grade 2: moderate, >1 cough lasting <5 seconds; Grade 3: coughing heavily and continuously for >5 seconds) | 24 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant experiencing tachycardia | Tachycardia is defined as heart rate >100 beats per minute | 24 hours perioperative | 
| Number of participant experiencing bradycardia | Bradycardia is defined as heart rate <60 beats per minute | 24 hours perioperative | 
| Number of participant experiencing hypertension | Increase of blood pressure >20% from initial blood pressure | 24 hours perioperative | 
| Number of participant experiencing hypotension | Decrease of blood pressure <20% from initial blood pressure | 24 hours perioperative |