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

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06040034
• Other study ID #: AN-202309.01
• Status: Completed
• Phase: Phase 2
• Start date: February 2, 2023
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2023
• Source: Universitas Padjadjaran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Lidocaine IV
Lidocaine given as bolus or continuous infusion.

Locations

Country	Name	City	State
Indonesia	Hasan Sadikin General Hospital	Bandung	West Java

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Padjadjaran

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participant experiencing tachycardia	Tachycardia is defined as heart rate >100 beats per minute	24 hours perioperative
Secondary	Number of participant experiencing bradycardia	Bradycardia is defined as heart rate <60 beats per minute	24 hours perioperative
Secondary	Number of participant experiencing hypertension	Increase of blood pressure >20% from initial blood pressure	24 hours perioperative
Secondary	Number of participant experiencing hypotension	Decrease of blood pressure <20% from initial blood pressure	24 hours perioperative