Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reducing Cough During Extubation
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 164
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomized controled trial was conducted. the investigator allocated patient into two arms. 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
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in incidence of coughing
timeFrame: the incidence was recorded during extubation and immediatly extubation
Secondary outcomes:
measure: Severity of coughing
timeFrame: the severity was recorded during extubation and immediatly extubation
measure: Incidence of postoperative sore throat
timeFrame: the incidence was recorded within 24 hr after extubation
measure: Incidence of dysphonia
timeFrame: the incidence was recorded within 24 hr after extubation
measure: Incidence of dysphagia
timeFrame: the incidence was recorded within 24 hr after extubation
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Khon Kaen University
Study officials:
affiliation: Khon Kaen University
name: PORNTHEP KASEMSIRI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.