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Completed

NCT Number: NCT04090112

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

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

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Key information

Conditions

Reducing Cough During Extubation

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Treatment and study plan

10% lidocaine sprayed

Drug

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

Other names: 10% Xylociane

2% lidocaine intravenous

Drug

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

Other names: 2% Xylocaine

Primary outcomes

  1. Change in incidence of coughing

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

    Coughing event was recorded by blinded anesthesiologist

Secondary outcomes

  1. Severity of coughing

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

    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

  2. Incidence of postoperative sore throat

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

    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.

  3. Incidence of dysphonia

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

    Incidence of dysphonia was recorded by two blinded anesthetist nurses .

  4. Incidence of dysphagia

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

    Incidence of dysphagia was recorded by two blinded anesthetist nurses .

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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: A Prospective Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2019
Registry last updated
Sep 16, 2019

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.