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

• ClinicalTrials.gov Identifier: NCT06040034
• Recruitment Status: Completed
• First Posted: September 15, 2023
• Last Update Posted: September 22, 2023
• Sponsor: Universitas Padjadjaran
• Information provided by (Responsible Party): Universitas Padjadjaran

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cough	Drug: Lidocaine IV	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Comparison
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients
• Actual Study Start Date: February 2, 2023
• Actual Primary Completion Date: May 1, 2023
• Actual Study Completion Date: May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Post-Extubation Cough Grade [ Time Frame: 24 hours post operative ]

   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)

Secondary Outcome Measures :

1. Number of participant experiencing tachycardia [ Time Frame: 24 hours perioperative ]
   Tachycardia is defined as heart rate >100 beats per minute
2. Number of participant experiencing bradycardia [ Time Frame: 24 hours perioperative ]
   Bradycardia is defined as heart rate <60 beats per minute
3. Number of participant experiencing hypertension [ Time Frame: 24 hours perioperative ]
   Increase of blood pressure >20% from initial blood pressure
4. Number of participant experiencing hypotension [ Time Frame: 24 hours perioperative ]
   Decrease of blood pressure <20% from initial blood pressure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Indonesia

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia, 40161

Sponsors and Collaborators

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

More Information

• Responsible Party: Universitas Padjadjaran
• ClinicalTrials.gov Identifier: NCT06040034
• Other Study ID Numbers: AN-202309.01
• First Posted: September 15, 2023
• Last Update Posted: September 22, 2023
• Last Verified: September 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action