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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
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore Throat

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 20, 2016
    Last Updated
    October 30, 2016
    Sponsor
    Keimyung University Dongsan Medical Center
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    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

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    Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff

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