Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Sur… (NCT07491991) | Clinical Trial Compass
CompletedPhase 4
Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Surgery
China96 participantsStarted 2025-03-02
Plain-language summary
Postoperative sore throat is a common complication following tracheal intubation under general anesthesia for thyroidectomy. The special surgical position for thyroidectomy, as well as the physical and electrical stimulation from nerve-monitoring endotracheal tubes, can aggravate mucosal injury and inflammatory response at the glottis, which significantly reduces patients' postoperative comfort and hinders enhanced recovery after surgery. Glottic nebulization is an effective non-invasive approach for alleviating pharyngeal and laryngeal complications. Budesonide combined with lidocaine has potential efficacy in relieving sore throat, yet its therapeutic effect on postoperative sore throat after thyroidectomy with nerve monitoring remains unclear. This study aims to investigate the improvement effect of glottic nebulization with budesonide combined with lidocaine versus normal saline after tracheal intubation during the perioperative period on postoperative sore throat in patients undergoing thyroidectomy with nerve monitoring. Meanwhile, it analyzes the impacts of nebulization with different medications on the severity of postoperative sore throat and the incidence of related adverse reactions, so as to provide evidence-based evidence for the clinical selection of prophylactic and therapeutic drugs for postoperative sore throat in such surgeries.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants have a full understanding of the purpose and significance of this trial, voluntarily participate in the trial, and sign the informed consent form;
* Undergoing thyroidectomy with nerve monitoring under general anesthesia (with successful tracheal intubation at the first attempt);
* Aged 18 to 60 years, regardless of gender;
* Body mass index (BMI) ranging from 18 kg/m² to 30 kg/m²;
* Surgical duration of 1 to 4 hours;
* American Society of Anesthesiologists (ASA) physical status classification Grade I-II;
* No contraindications to the study drugs.
Exclusion Criteria:
* Current smokers or patients with pre-operative sore throat;
* A recent history of upper or lower respiratory tract infection;
* Patients who refuse to participate in this study;
* Complicated with significant hepatic, renal or other organ dysfunction;
* Pregnancy or lactation period;
* Patients with a Mallampati classification of Grade Ⅲ or above (Mallampati classification \>2);
* Nasogastric tube required during surgery;
* Reoperative thyroidectomy;
* Pre-operative administration of non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics;
* Patients with chronic pharyngitis or gastroesophageal reflux disease (GERD);
* More than two attempts of tracheal intubation by an experienced anesthesiologist;
* Patients with a known allergy to the study drugs.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of postoperative sore throat
Timeframe: within the first 24 postoperative hours