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

Phase 2

Completed

• Conditions: Cough
• Interventions: Drug: Lidocaine IV

• Registration Number: NCT06040034
• Lead Sponsor: Universitas Padjadjaran

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-02
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-10
• Study First Submitted QC: 2023-09-10
• Study First Posted: 2023-09-15
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Lidocaine Intravenous Infusion	Lidocaine IV	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.
Bolus Lidocaine Intravenous	Lidocaine IV	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.

Primary Outcome Measures

Name	Time	Method
Post-Extubation Cough Grade	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

Name	Time	Method
Number of participant experiencing tachycardia	24 hours perioperative	Tachycardia is defined as heart rate \>100 beats per minute
Number of participant experiencing hypertension	24 hours perioperative	Increase of blood pressure \>20% from initial blood pressure
Number of participant experiencing hypotension	24 hours perioperative	Decrease of blood pressure \<20% from initial blood pressure
Number of participant experiencing bradycardia	24 hours perioperative	Bradycardia is defined as heart rate \<60 beats per minute

Trial Locations

Locations (1)

Hasan Sadikin General Hospital; 🇮🇩 Bandung, West Java, Indonesia