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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Lidocaine Intravenous Infusion | Active Comparator | 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. |
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| Bolus Lidocaine Intravenous | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine IV | Drug | Lidocaine given as bolus or continuous infusion. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iwan Fuadi, MD | Faculty of Medicine Universitas Padjadjaran Bandung | Study Director |
| Ardi Zulfariansyah, MD | Faculty of Medicine Universitas Padjadjaran Bandung | Study Director |
| Ignatia K Hallis, MD | Faculty of Medicine Universitas Padjadjaran Bandung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasan Sadikin General Hospital | Bandung | West Java | 40161 | Indonesia |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Comparison
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| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |