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

Sponsor

Universitas Padjadjaran (Other)

Overall Status

Completed

CT.gov ID

NCT06040034

Collaborator

(none)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

13.8

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

ComparisonComparison

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 :

Feb 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.

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

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

Number of participant experiencing tachycardia [24 hours perioperative]
Tachycardia is defined as heart rate >100 beats per minute
Number of participant experiencing bradycardia [24 hours perioperative]
Bradycardia is defined as heart rate <60 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitas Padjadjaran

ClinicalTrials.gov Identifier:

NCT06040034

Other Study ID Numbers:

AN-202309.01

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 22, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cough

Lidocaine

Study Results

No Results Posted as of Sep 22, 2023