Back to resultsComparison 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
Primary Purpose
Reducing Cough During Extubation
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
10% lidocaine sprayed
2% lidocaine intravenous
Sponsored by
About this trial
This is an interventional treatment trial for Reducing Cough During Extubation
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
Sites / Locations
- Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
the study group (Group A)
Comparator group (Group B)
Arm Description
Patients received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet
Patients received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation
Outcomes
Primary Outcome Measures
Change in incidence of coughing
Coughing event was recorded by blinded anesthesiologist
Secondary Outcome Measures
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
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.
Incidence of dysphonia
Incidence of dysphonia was recorded by two blinded anesthetist nurses .
Incidence of dysphagia
Incidence of dysphagia was recorded by two blinded anesthetist nurses .
Full Information
NCT ID
NCT04090112
First Posted
September 13, 2019
Last Updated
September 13, 2019
Sponsor
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT04090112
Brief 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
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reducing Cough During Extubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantOutcomes Assessor
Masking Description
The study based on a sequentially numbered list were prepared in the same way. Participant and outcome assessor were blined to the computer generated lists
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the study group (Group A)
Arm Type
Experimental
Arm Description
Patients received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet
Arm Title
Comparator group (Group B)
Arm Type
Active Comparator
Arm Description
Patients received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation
Intervention Type
Drug
Intervention Name(s)
10% lidocaine sprayed
Other Intervention Name(s)
10% Xylociane
Intervention Description
four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet
Intervention Type
Drug
Intervention Name(s)
2% lidocaine intravenous
Other Intervention Name(s)
2% Xylocaine
Intervention Description
15 mg/kg of 2% lidocaine intravenous injection prior to extubation
Primary Outcome Measure Information:
Title
Change in incidence of coughing
Description
Coughing event was recorded by blinded anesthesiologist
Time Frame
the incidence was recorded during extubation and immediatly extubation
Secondary Outcome Measure Information:
Title
Severity of coughing
Description
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
Title
Incidence of postoperative sore throat
Description
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
Title
Incidence of dysphonia
Description
Incidence of dysphonia was recorded by two blinded anesthetist nurses .
Time Frame
the incidence was recorded within 24 hr after extubation
Title
Incidence of dysphagia
Description
Incidence of dysphagia was recorded by two blinded anesthetist nurses .
Time Frame
the incidence was recorded within 24 hr after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PORNTHEP KASEMSIRI
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
23370978
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.
Results Reference
result
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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
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