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

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

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

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Drug: Lidocaine IV

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Bandung, West Java, Indonesia, 40161
      • Hasan Sadikin General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Lidocaine Intravenous Infusion; 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; Lidocaine given as bolus or continuous infusion.
Active Comparator: Bolus Lidocaine Intravenous; 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; Lidocaine given as bolus or continuous infusion.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Investigators: Study Director: Iwan Fuadi, MD, Faculty of Medicine Universitas Padjadjaran Bandung; Study Director: Ardi Zulfariansyah, MD, Faculty of Medicine Universitas Padjadjaran Bandung; Principal Investigator: Ignatia K Hallis, MD, Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: September 10, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: AN-202309.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No