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Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough (ELIT)

Primary Purpose

Postoperative Sore Throat, Postoperative Cough

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cuff inflation with air
cuff inflation with lidocaine 1%
cuff inflation with lidocaine 2%
Induction of anesthesia
Maintenance of anesthesia
Endotracheal intubation
Systematic post-operative analgesia
Sponsored by
Ogarite Habib
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Sore Throat focused on measuring Lidocaine 1%, Lidocaine 2%, Endotracheal tube cuff, Cuff inflation, Postoperative sore throat, Postoperative cough, General anesthesia, Endotracheal intubation

Eligibility Criteria

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

Inclusion Criteria:

  • Patients over 18 years old
  • American Society of Anesthesiologists classification (ASA) category 1 or 2
  • High pressure, low volume endotracheal tube - (Lo-pro)

Exclusion Criteria:

  • Ear nose and throat and cranial surgery
  • Ear nose and throat pathologies
  • Asthma and bronchial hyperreactivity
  • Chronic cough
  • Diabetes
  • Cognitive disorders
  • Swallowing disorders
  • Corticotherapy during the last week
  • Allergy to lidocaine
  • Urgent surgery
  • Nasogastric, oro-gastric
  • Ventral position
  • More than 2 intubation attempts
  • Continuous intravenous infusion of lidocaine intraoperatively.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Air

    Lidocaine 1%

    Lidocaine 2%

    Arm Description

    Endotracheal tube cuff inflation with air

    Endotracheal tube cuff inflation with Lidocaine 1%

    Endotracheal tube cuff inflation with Lidocaine 2%

    Outcomes

    Primary Outcome Measures

    Sore throat intensity 0
    Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
    Sore throat intensity 2
    Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
    Sore throat intensity 6
    Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
    Sore throat intensity 24
    Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
    Cough intensity 0
    Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
    Cough intensity 2
    Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
    Cough intensity 6
    Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
    Cough intensity 24
    Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2018
    Last Updated
    January 11, 2019
    Sponsor
    Ogarite Habib
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03792776
    Brief Title
    Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough
    Acronym
    ELIT
    Official Title
    Effect of Lidocaine 1% and 2% in the Endotracheal Tube Cuff on Postoperative Sore Throat and Cough
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    April 2019 (Anticipated)
    Study Completion Date
    October 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ogarite Habib

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).
    Detailed Description
    Eligible patients undergoing general anesthesia will be randomized and assigned to three groups: Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2% The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg. Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention). The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O). The volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from the local toxicity of the local anesthetic in case of accidental rupture of the balloon. All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Sore Throat, Postoperative Cough
    Keywords
    Lidocaine 1%, Lidocaine 2%, Endotracheal tube cuff, Cuff inflation, Postoperative sore throat, Postoperative cough, General anesthesia, Endotracheal intubation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Air
    Arm Type
    Active Comparator
    Arm Description
    Endotracheal tube cuff inflation with air
    Arm Title
    Lidocaine 1%
    Arm Type
    Experimental
    Arm Description
    Endotracheal tube cuff inflation with Lidocaine 1%
    Arm Title
    Lidocaine 2%
    Arm Type
    Experimental
    Arm Description
    Endotracheal tube cuff inflation with Lidocaine 2%
    Intervention Type
    Other
    Intervention Name(s)
    cuff inflation with air
    Intervention Description
    Endotracheal tube cuff inflation with air
    Intervention Type
    Drug
    Intervention Name(s)
    cuff inflation with lidocaine 1%
    Intervention Description
    Endotracheal tube cuff inflation with lidocaine 1%
    Intervention Type
    Drug
    Intervention Name(s)
    cuff inflation with lidocaine 2%
    Intervention Description
    Endotracheal tube cuff inflation with lidocaine 2%
    Intervention Type
    Other
    Intervention Name(s)
    Induction of anesthesia
    Intervention Description
    The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.
    Intervention Type
    Other
    Intervention Name(s)
    Maintenance of anesthesia
    Intervention Description
    Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).
    Intervention Type
    Other
    Intervention Name(s)
    Endotracheal intubation
    Intervention Description
    The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).
    Intervention Type
    Other
    Intervention Name(s)
    Systematic post-operative analgesia
    Intervention Description
    All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.
    Primary Outcome Measure Information:
    Title
    Sore throat intensity 0
    Description
    Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
    Time Frame
    hour 0 after extubation
    Title
    Sore throat intensity 2
    Description
    Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
    Time Frame
    at 2 hours after extubation
    Title
    Sore throat intensity 6
    Description
    Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
    Time Frame
    at 6 hours after extubation
    Title
    Sore throat intensity 24
    Description
    Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
    Time Frame
    at 24 hours after extubation
    Title
    Cough intensity 0
    Description
    Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
    Time Frame
    hour 0 after extubation
    Title
    Cough intensity 2
    Description
    Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
    Time Frame
    at 2 hours after extubation
    Title
    Cough intensity 6
    Description
    Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
    Time Frame
    at 6 hours after extubation
    Title
    Cough intensity 24
    Description
    Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
    Time Frame
    at 24 hours after extubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years old American Society of Anesthesiologists classification (ASA) category 1 or 2 High pressure, low volume endotracheal tube - (Lo-pro) Exclusion Criteria: Ear nose and throat and cranial surgery Ear nose and throat pathologies Asthma and bronchial hyperreactivity Chronic cough Diabetes Cognitive disorders Swallowing disorders Corticotherapy during the last week Allergy to lidocaine Urgent surgery Nasogastric, oro-gastric Ventral position More than 2 intubation attempts Continuous intravenous infusion of lidocaine intraoperatively.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ogarite P Habib, MD
    Phone
    +9613722518
    Email
    Ogarite.habib@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hicham Jabbour, MD
    Organizational Affiliation
    Saint JU
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough

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