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

Effects of Preoperative Gum Chewing on Postoperative Sore Throat After Double-lumen Endobronchial Tube Intubation: A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Pharyngeal Diseases; Thoracic Surgery, Video-Assisted; Chewing Gum
• Intervention / Treatment: Dietary supplement: Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gum group; 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.	Dietary supplement: Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia; 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes in recovery room and 2 hours after extubation
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.	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	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).	At 30 minutes in recovery room, and at 2 and 24 hours after extubation
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).	24 hours after extubation
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).	30 minutes in recovery room and 2 hours after extubation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 24, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Pharyngeal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2308-119-1459

Drug and device information, study documents

• 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