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

NCT ID: NCT06040034

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2023-05-01

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

Conditions

Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type: DRUG

Lidocaine given as bolus or continuous infusion.

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type: DRUG

Lidocaine given as bolus or continuous infusion.

Interventions

Lidocaine IV

Lidocaine given as bolus or continuous infusion.

Intervention Type: DRUG

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
• Liver dysfunction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iwan Fuadi, MD

Role: STUDY_DIRECTOR

Faculty of Medicine Universitas Padjadjaran Bandung

Ardi Zulfariansyah, MD

Role: STUDY_DIRECTOR

Faculty of Medicine Universitas Padjadjaran Bandung

Ignatia K Hallis, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Countries

Indonesia

Other Identifiers

AN-202309.01

Identifier Type: -

Identifier Source: org_study_id