Thoracic Surgery, Video-AssistedNCT06061250
Effect of Gum Chewing on Sore Throat After Double-lumen Tube Intubation
A study testing Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia in people with Thoracic Surgery, Video-Assisted and Chewing Gum, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Thoracic Surgery, Video-Assisted, Chewing Gum, Pharyngeal Diseases
- What is being tested?
- Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia
- Medical subject headings
- Pharyngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesiaDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after extubation
Secondary outcomes (5)
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).
Measured: 24 hours after extubation
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.
Measured: 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
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).
Measured: 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.
Measured: 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).
Measured: At 30 minutes in recovery room, and at 2 and 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start24 Oct 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Why it stopped: The study has not commenced due to medical staff strikes and staffing shortages.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery, Video-AssistedStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hojin Lee, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061250
- Sponsor's protocol ID
- 2308-119-1459
- Status last verified
- May 2025
- First submitted
- 21 Sep 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Gum Chewing on Postoperative Sore Throat After Double-lumen Endobronchial Tube Intubation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06061250
- Acronym / sponsor ID
- 2308-119-1459
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has not commenced due to medical staff strikes and staffing shortages.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Oct 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gum group | Experimental | Dietary Supplement: Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesiaThis 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. |
| 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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesiaTo 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. | Dietary supplement | Gum group |
Primary outcome
Incidence of postoperative sore throat at 24 hours after extubation
Time frame: 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.
5 secondary outcomes
Intensity of postoperative sore throat at 24 hours after extubation
Time frame: 24 hours after extubation
Incidence of postoperative sore throat at 30 minutes in recovery room and 2 hours after extubation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 30 minutes in recovery room, and at 2 and 24 hours after extubation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing a piece of gum (Xylitol gum, LOTTE WELLFOOD, Korea) before induction of anesthesia in people with Thoracic Surgery, Video-Assisted and Chewing Gum, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative sore throat at 24 hours after extubation (time frame: 24 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.