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

NCT06061250 | Withdrawn

• 1 other identifier: 2308-119-1459
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intensity of postoperative sore throat at 24 hours after extubation

  24 hours after extubation

• Incidence of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation

  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

  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

  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

  At 30 minutes in recovery room, and at 2 and 24 hours after extubation

Study Arms (2)

Gum group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia DIETARY_SUPPLEMENT

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.

Gum group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Pharyngeal Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 29, 2023
• Study Start: October 24, 2023
• Primary Completion: August 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 18, 2025

Record last verified: 2025-05