Trials / Withdrawn
WithdrawnNCT06061250
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
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-10-24
- Primary completion
- 2024-08-31
- Completion
- 2024-10-31
- First posted
- 2023-09-29
- Last updated
- 2025-05-18
Source: ClinicalTrials.gov record NCT06061250. Inclusion in this directory is not an endorsement.