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

NCT06040034 | Completed Phase 2 DMC

• 1 other identifier: AN-202309.01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participant experiencing tachycardia

  24 hours perioperative

• Number of participant experiencing bradycardia

  24 hours perioperative

• Number of participant experiencing hypertension

  24 hours perioperative

• Number of participant experiencing hypotension

  24 hours perioperative

Study Arms (2)

Continuous Lidocaine Intravenous Infusion

ACTIVE COMPARATOR

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

Bolus Lidocaine Intravenous

ACTIVE COMPARATOR

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

Interventions

Lidocaine IV DRUG

Lidocaine given as bolus or continuous infusion.

Bolus Lidocaine Intravenous; Continuous Lidocaine Intravenous Infusion

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA class 1 and 2
• Thyroidectomy patients in Hasan Sadikin Bandung Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Iwan Fuadi, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY DIRECTOR

• Ardi Zulfariansyah, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY DIRECTOR

• Ignatia K Hallis, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: February 2, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ID (1)