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CompletedNCT04090112Updated Sep 16, 2019

Comparison of Effectiveness Between the Combination of Lidocaine Sprayed at Laryngeal Inlet and on the Cuff of Endotracheal Tube Versus Intravenous Lidocaine for Reducing Cough During Extubation

An interventional study of 10% lidocaine sprayed and 2% lidocaine intravenous in Reducing Cough During Extubation, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-09-16.

Sponsored by Khon Kaen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2018, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
All
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Study summary

Coughing during extubation of endotracheal tube (ETT) is a common problem that leads to poor surgical results including hemodynamic change, rebleeding at the surgical wound and wound dehiscence. Recently, lidocaine has been introduced for reducing coughing during extubation. However, data comparing routes of lidocaine application are lacking, thus, this study compared the combination of lidocaine sprayed on laryngeal inlet and cuff of ETT versus intravenous lidocaine injection for efficacy in reducing coughing

Read the detailed description

A prospective randomized control trial was conduct with 164 patients. They were randomly allocated into Gr. A and B. Group A received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation. The same general anesthesia protocol was applied in all of the patients. Incidence and severity of cough during extubation was evaluated. Furthermore, incidence of 24-hour postoperative adverse events (including sore throat, dysphagia, and hoarseness) and hemodynamic response after extubation were analyzed.

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Conditions studied

  • Reducing Cough During Extubation

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In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 164 is above the median of 70 across 263 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients who underwent elective surgery with American Society of Anesthesiologists physical status classifications of I and III

Exclusion criteria

Exclusion Criteria:

  • patients having body mass index more than 35 kg/m2, high risk of aspiration, chronic smokers more than ten pack-years, chronic cough or recent upper respiratory infection, suspected difficult airway, retained ETT prior surgery, surgery at oral cavity, neck and thoracic region, operative time more than 120 minutes or less than 30 minutes, and history of lidocaine allergy
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    the study group (Group A)

    Patients received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet

    Drug: 10% lidocaine sprayed

  • Active comparator
    Comparator group (Group B)

    Patients received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation

    Drug: 2% lidocaine intravenous

Interventions

  • Drug10% lidocaine sprayed

    four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet

    Also known as: 10% Xylociane

  • Drug2% lidocaine intravenous

    15 mg/kg of 2% lidocaine intravenous injection prior to extubation

    Also known as: 2% Xylocaine

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What researchers measure

Primary outcomes

  1. Change in incidence of coughing

    Coughing event was recorded by blinded anesthesiologist

    Time frame: the incidence was recorded during extubation and immediatly extubation

Secondary outcomes

  1. Severity of coughing

    the severity of cough was recorded by blinded anesthesiologist. Coughing level severity (16) was evaluated as 0 = no cough; 1 = slight cough, cough without obvious contraction of abdomen; 2 = moderate cough, strong and sudden contraction of the abdomen lasting less than 5 seconds; 3 = severe cough, strong and sudden contraction of the abdomen sustained more than 5 seconds

    Time frame: the severity was recorded during extubation and immediatly extubation

  2. Incidence of postoperative sore throat

    Incidence of postoperative sore throat was recorded by two blinded anesthetist nurses . The numeric rating scale (0 = no, 10 = extreme) was used for evaluation of sore throat. If the numeric rating scale was more than 3, it was considered as a significant adverse event.

    Time frame: the incidence was recorded within 24 hr after extubation

  3. Incidence of dysphonia

    Incidence of dysphonia was recorded by two blinded anesthetist nurses .

    Time frame: the incidence was recorded within 24 hr after extubation

  4. Incidence of dysphagia

    Incidence of dysphagia was recorded by two blinded anesthetist nurses .

    Time frame: the incidence was recorded within 24 hr after extubation

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Study locations

1 site
  • Khon Kaen University
    Khon Kaen, 40002, Thailand
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References and documents

Publications

  • D'Aragon F, Beaudet N, Gagnon V, Martin R, Sansoucy Y. The effects of lidocaine spray and intracuff alkalinized lidocaine on the occurrence of cough at extubation: a double-blind randomized controlled trial. Can J Anaesth. 2013 Apr;60(4):370-6. doi: 10.1007/s12630-013-9896-8. Epub 2013 Feb 1. PubMed 23370978 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04090112
Lead sponsor
Khon Kaen University
Responsible party
Pornthep Kasemsiri (Clinical Associate Professor, Khon Kaen University) — Principal investigator
First posted
Sep 16, 2019
Start date
Sep 1, 2018
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Sep 16, 2019

Study contacts

PORNTHEP KASEMSIRI
principal investigator · Khon Kaen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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