Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
Primary Purpose
Sore Throat
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lidocaine jelly application
Normal saline application
Sponsored by
About this trial
This is an interventional prevention trial for Sore Throat
Eligibility Criteria
Inclusion Criteria:
- ASA I-III
- Patients scheduled for general anesthesia with endotracheal intubation
- Patients scheduled for surgery which duration is expected to less than 3 hr
Exclusion Criteria:
- Difficult airway
- Rapid sequence induction
- Recent sore throat
- Recent upper respiratory infection
- Asthma
- Chronic obstructive pulmonary disease
- Chronic cough
- Pregnancy
- Allergy to lidocaine
- Friable teeth
- History of head and neck surgery
- Multiple intubation attempts
- Regional anesthetic agents
- Gastric tube
- Dexamethasone
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Control
Lidocaine
Arm Description
Normal saline will be applied to the endotracheal tube.
Lidocaine jelly will be applied to the endotracheal tube.
Outcomes
Primary Outcome Measures
Number of participants with sore throat
Secondary Outcome Measures
Number of participants with sore throat
Number of participants with hoarseness
Number of participants with throat numbness
Number of participants with nausea
Number of participants with vomiting
Number of participants with cough
Number of participants with dry mouth
Number of participants with additional pain medication
Full Information
NCT ID
NCT02952157
First Posted
October 20, 2016
Last Updated
October 30, 2016
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02952157
Brief Title
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
Official Title
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keimyung University Dongsan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Normal saline will be applied to the endotracheal tube.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine jelly will be applied to the endotracheal tube.
Intervention Type
Drug
Intervention Name(s)
Lidocaine jelly application
Intervention Type
Drug
Intervention Name(s)
Normal saline application
Primary Outcome Measure Information:
Title
Number of participants with sore throat
Time Frame
At 24 hr
Secondary Outcome Measure Information:
Title
Number of participants with sore throat
Time Frame
At 1, 6, and 12 hr
Title
Number of participants with hoarseness
Time Frame
At 1, 6, 12 and 24 hr
Title
Number of participants with throat numbness
Time Frame
At 1, 6, 12 and 24 hr
Title
Number of participants with nausea
Time Frame
At 1, 6, 12 and 24 hr
Title
Number of participants with vomiting
Time Frame
At 1, 6, 12 and 24 hr
Title
Number of participants with cough
Time Frame
At 1, 6, 12 and 24 hr
Title
Number of participants with dry mouth
Time Frame
At 1, 6, 12 and 24 hr
Title
Number of participants with additional pain medication
Time Frame
At 24 hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-III
Patients scheduled for general anesthesia with endotracheal intubation
Patients scheduled for surgery which duration is expected to less than 3 hr
Exclusion Criteria:
Difficult airway
Rapid sequence induction
Recent sore throat
Recent upper respiratory infection
Asthma
Chronic obstructive pulmonary disease
Chronic cough
Pregnancy
Allergy to lidocaine
Friable teeth
History of head and neck surgery
Multiple intubation attempts
Regional anesthetic agents
Gastric tube
Dexamethasone
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff
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