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Clinical Trials/NCT06040034
NCT06040034
Completed
Phase 2

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

Universitas Padjadjaran1 site in 1 country40 target enrollmentFebruary 2, 2023
ConditionsCough
InterventionsLidocaine IV

Overview

Phase
Phase 2
Intervention
Lidocaine IV
Conditions
Cough
Sponsor
Universitas Padjadjaran
Enrollment
40
Locations
1
Primary Endpoint
Post-Extubation Cough Grade
Status
Completed
Last Updated
2 years ago

Overview

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
Registry
clinicaltrials.gov
Start Date
February 2, 2023
End Date
May 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

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.

Intervention: Lidocaine IV

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.

Intervention: Lidocaine IV

Outcomes

Primary Outcomes

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 Outcomes

  • Number of participant experiencing tachycardia(24 hours perioperative)
  • Number of participant experiencing hypertension(24 hours perioperative)
  • Number of participant experiencing hypotension(24 hours perioperative)
  • Number of participant experiencing bradycardia(24 hours perioperative)

Study Sites (1)

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