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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06040034
Enrollment
40
Registered
2023-09-15
Start date
2023-02-02
Completion date
2023-05-01
Last updated
2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

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

Interventions

DRUGLidocaine IV

Lidocaine given as bolus or continuous infusion.

Sponsors

Universitas Padjadjaran
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

Comparison

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-Extubation Cough Grade24 hours post operativeCough 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

MeasureTime frameDescription
Number of participant experiencing tachycardia24 hours perioperativeTachycardia is defined as heart rate \>100 beats per minute
Number of participant experiencing bradycardia24 hours perioperativeBradycardia is defined as heart rate \<60 beats per minute
Number of participant experiencing hypertension24 hours perioperativeIncrease of blood pressure \>20% from initial blood pressure
Number of participant experiencing hypotension24 hours perioperativeDecrease of blood pressure \<20% from initial blood pressure

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026