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OpenTrials
Completed

NCT Number: NCT06040034

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

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

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine IV

Drug

Lidocaine given as bolus or continuous infusion.

Primary outcomes

  1. Post-Extubation Cough Grade

    Time frame: 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 outcomes

  1. Number of participant experiencing tachycardia

    Time frame: 24 hours perioperative

    Tachycardia is defined as heart rate >100 beats per minute

  2. Number of participant experiencing bradycardia

    Time frame: 24 hours perioperative

    Bradycardia is defined as heart rate <60 beats per minute

  3. Number of participant experiencing hypertension

    Time frame: 24 hours perioperative

    Increase of blood pressure >20% from initial blood pressure

  4. Number of participant experiencing hypotension

    Time frame: 24 hours perioperative

    Decrease of blood pressure <20% from initial blood pressure

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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