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Effect of Gum Chewing on Sore Throat After Double-lumen Tube Intubation

Primary Purpose

Thoracic Surgery, Video-Assisted, Chewing Gum, Pharyngeal Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thoracic Surgery, Video-Assisted

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 19-75 years undergoing routine video-assisted thoracoscopic surgery scheduled for double-lumen tube intubation Patients who are able to provide written informed consent to participate in the study and understand the procedures of this study American Society of Anesthesiologists physical status classification (ASA physical status classification) grade 1-2 Exclusion Criteria: Patients who have not consented to the study American Society of Anesthesiologists physical status classification (ASA physical status classification) grade 3-4 Patients with poor dental health that limits chewing gum or tracheal intubation Patients who are expected to be difficult to intubate Patients with a history of aspiration pneumonia Patients being treated for chronic laryngitis, chronic bronchitis, asthma, reflux esophagitis Patients with a history of smoking within the past week Patients who have difficulty communicating or carrying out gum chewing and spitting instructions Patients with hypersensitivity to Xylitol gum ingredients Patients taking narcotic analgesics, antidepressants, and anticonvulsants for chronic pain Patients requiring endotracheal intubation or intensive care unit treatment after surgery Patients who, in the opinion of the investigator or study staff, are not appropriate candidates for this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Gum group

    Control group

    Arm Description

    This group of patients will receive a piece of Xylitol gum (LOTTE WELLFOOD, Korea) 10 minutes before induction of anesthesia. Patients will chew it for 2 minutes and spit out. Other anesthetic care will follow routine protocol of the hospital.

    This group of patients will instructed to swallow their saliva twice 10 minutes before induction of anesthesia. Other anesthetic care will follow routine protocol of the hospital.

    Outcomes

    Primary Outcome Measures

    Incidence of postoperative sore throat at 24 hours after extubation
    Incidence of postoperative sore throat at 24 hours after extubation, described as percentage of patients with sore throat out of all patients in the same group.

    Secondary Outcome Measures

    Intensity of postoperative sore throat at 24 hours after extubation
    Intensity of postoperative sore throat at 24 hours after extubation, assessed with 11-point numeric rating scale (minimal value 0 representing absence of pain, maximal value 10 representing the worst possible pain).
    Incidence of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation
    Incidence of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation, described as percentage of patients with sore throat out of all patients in the same group.
    Intensity of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation
    Intensity of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation, assessed with 11-point numeric rating scale (minimal value 0 representing absence of pain, maximal value 10 representing the worst possible pain).
    Incidence of hoarseness at 30 minutes in recovery room, and at 2 and 24 hours after extubation
    Incidence of hoarseness at 30 minutes in recovery room, and at 2 and 24 hours after extubation, described as percentage of patients with hoarseness out of all patients in the same group.
    Intensity of hoarseness at 30 minutes in recovery room, and at 2 and 24 hours after extubation
    Intensity of hoarseness at 30 minutes in recovery room, and at 2 and 24 hours after extubation, assessed with 4-step scale (none, mild, moderate, and severe).

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06061250
    Brief Title
    Effect of Gum Chewing on Sore Throat After Double-lumen Tube Intubation
    Official Title
    Effects of Preoperative Gum Chewing on Postoperative Sore Throat After Double-lumen Endobronchial Tube Intubation: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 16, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Hospital

    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
    Patients undergoing video-assisted thoracoscopic surgery requiring double-lumen tube intubation are randomized into two groups; gum group and control group. In the gum group, patients are instructed to chew gum for 2 minutes, approximately 10 minutes before induction of anesthesia. Patients in the control group are instructed to swallow saliva twice. Postoperative sore throat and hoarseness are assessed 30 minutes after recovery room admission, and at 2 and 24 hours after extubation.
    Detailed Description
    Patients scheduled for video-assisted thoracoscopic surgery requiring double-lumen tube intubation and who agree to participate in the study are randomized to the gum chewing group and the control group. All clinical procedures are identical in both groups except for preoperative gum chewing. The gum chewing group chew gum for approximately 2 minutes, 10 minutes before induction of anesthesia. The control group do not chew gum and be induced to swallow saliva twice at the same time point. All patients are endotracheally intubated with a double-lumen tube using video laryngoscopy to provide unilateral pulmonary ventilation. Extubation is performed according to routine procedures, and the tube is assessed with whether there are blood stains at extubation. At 30 minutes in the recovery room and at 2 hours and 24 hours after extubation, the patient's sore throat is assessed for presence and intensity assessed by a 11-point numerical pain scale (minimal value 0 representing absence of pain, maximal value 10 representing the worst possible pain). Hoarseness at the same time points is also assessed for presence and severity. The presence of intubation-related complications (aspiration pneumonia) is assessed as a safety measure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thoracic Surgery, Video-Assisted, Chewing Gum, Pharyngeal Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two separate groups of patients will undergo same anesthetic procedure, except for chewing a gum for 2 minutes or swallowing saliva twice 10 minutes before the induction of anesthesia.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    192 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gum group
    Arm Type
    Experimental
    Arm Description
    This group of patients will receive a piece of Xylitol gum (LOTTE WELLFOOD, Korea) 10 minutes before induction of anesthesia. Patients will chew it for 2 minutes and spit out. Other anesthetic care will follow routine protocol of the hospital.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    This group of patients will instructed to swallow their saliva twice 10 minutes before induction of anesthesia. Other anesthetic care will follow routine protocol of the hospital.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia
    Intervention Description
    To replicate Xylitol chewing gum, which has been shown to reduce postoperative sore throat in previous studies of single-lumen endotracheal tubes and supraglottic airways, the investigators will use a commercially available gum from South Korea.
    Primary Outcome Measure Information:
    Title
    Incidence of postoperative sore throat at 24 hours after extubation
    Description
    Incidence of postoperative sore throat at 24 hours after extubation, described as percentage of patients with sore throat out of all patients in the same group.
    Time Frame
    24 hours after extubation
    Secondary Outcome Measure Information:
    Title
    Intensity of postoperative sore throat at 24 hours after extubation
    Description
    Intensity of postoperative sore throat at 24 hours after extubation, assessed with 11-point numeric rating scale (minimal value 0 representing absence of pain, maximal value 10 representing the worst possible pain).
    Time Frame
    24 hours after extubation
    Title
    Incidence of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation
    Description
    Incidence of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation, described as percentage of patients with sore throat out of all patients in the same group.
    Time Frame
    30 minutes in recovery room and 2 hours after extubation
    Title
    Intensity of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation
    Description
    Intensity of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation, assessed with 11-point numeric rating scale (minimal value 0 representing absence of pain, maximal value 10 representing the worst possible pain).
    Time Frame
    30 minutes in recovery room and 2 hours after extubation
    Title
    Incidence of hoarseness at 30 minutes in recovery room, and at 2 and 24 hours after extubation
    Description
    Incidence of hoarseness at 30 minutes in recovery room, and at 2 and 24 hours after extubation, described as percentage of patients with hoarseness out of all patients in the same group.
    Time Frame
    At 30 minutes in recovery room, and at 2 and 24 hours after extubation
    Title
    Intensity of hoarseness at 30 minutes in recovery room, and at 2 and 24 hours after extubation
    Description
    Intensity of hoarseness at 30 minutes in recovery room, and at 2 and 24 hours after extubation, assessed with 4-step scale (none, mild, moderate, and severe).
    Time Frame
    At 30 minutes in recovery room, and at 2 and 24 hours after extubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 19-75 years undergoing routine video-assisted thoracoscopic surgery scheduled for double-lumen tube intubation Patients who are able to provide written informed consent to participate in the study and understand the procedures of this study American Society of Anesthesiologists physical status classification (ASA physical status classification) grade 1-2 Exclusion Criteria: Patients who have not consented to the study American Society of Anesthesiologists physical status classification (ASA physical status classification) grade 3-4 Patients with poor dental health that limits chewing gum or tracheal intubation Patients who are expected to be difficult to intubate Patients with a history of aspiration pneumonia Patients being treated for chronic laryngitis, chronic bronchitis, asthma, reflux esophagitis Patients with a history of smoking within the past week Patients who have difficulty communicating or carrying out gum chewing and spitting instructions Patients with hypersensitivity to Xylitol gum ingredients Patients taking narcotic analgesics, antidepressants, and anticonvulsants for chronic pain Patients requiring endotracheal intubation or intensive care unit treatment after surgery Patients who, in the opinion of the investigator or study staff, are not appropriate candidates for this study

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Gum Chewing on Sore Throat After Double-lumen Tube Intubation

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