NCT07491991

Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Surgery

Evaluation of the Efficacy of Different Drugs Nebulized at the Glottis on Postoperative Sore Throat in Thyroid Surgery With Nerve Monitoring: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Postoperative sore throat is a common complication of thyroidectomy under general anesthesia. Multiple factors such as the special surgical position for thyroidectomy and the physical and electrical stimulation from nerve-monitoring endotracheal tubes can aggravate mucosal injury and inflammatory response at the glottis, increase the incidence of postoperative sore throat, and may also be accompanied by adverse reactions such as cough, hoarseness and dysphagia. These issues significantly reduce patients' postoperative comfort and hinder the process of enhanced postoperative recovery. As a non-invasive local drug administration method, glottic nebulization can act directly on the damaged mucous membrane of the pharynx and larynx, increase the local drug concentration, and exhibit significant advantages in alleviating pharyngolaryngeal inflammation and pain. Budesonide combined with lidocaine has potential preventive and therapeutic effects on postoperative sore throat, yet its efficacy and clinical application value in glottic nebulization for thyroidectomy with nerve monitoring have not been systematically verified. This study aims to systematically evaluate the preventive and therapeutic efficacy of glottic nebulization with budesonide combined with lidocaine versus normal saline after tracheal intubation on postoperative sore throat in patients undergoing thyroidectomy with nerve monitoring, and to clarify the impact of nebulization with different drugs on the incidence of postoperative sore throat. Meanwhile, it analyzes the improvement effect of nebulization with different drugs on the four-point scale scores and NRS scores of sore throat at immediate extubation, 12 hours and 24 hours after surgery, and explores its regulatory effect on the severity and duration of sore throat. In addition, this study will observe the impacts of different drug nebulization regimens on the occurrence of related adverse reactions such as cough, hoarseness and dysphagia in patients after surgery, as well as indicators including blood-stained endotracheal tube at extubation, operation duration and postoperative intubation time. It comprehensively compares the efficacy and safety of the two nebulization regimens, so as to provide scientific and reliable evidence-based medical evidence for the clinical formulation of individualized preventive and therapeutic regimens for postoperative sore throat in thyroidectomy with nerve monitoring, further optimize the perioperative management strategy for such surgeries, and improve patients' postoperative comfort and the level of enhanced postoperative recovery.

Conditions

• Postoperative Pain
• NEBULIZATION
• Thyroid Surgery

Interventions

Type	Name	Description
DRUG	Inhalation of budesonide combined with lidocaine	Following anesthesia induction, tracheal intubation was performed. The patients received continuous nebulization of 1 mg (2 mL) budesonide combined with 4 mL of 2% lidocaine at the glottis. The control group received 5 mL of normal saline via nebulization at the glottis.
OTHER	Inhalation of saline solution via nebulization	After anesthesia induction, tracheal intubation was performed, and the patient received continuous nebulization of 5 mL normal saline at the glottis.

Timeline

• Start date: 2025-03-02
• Primary completion: 2026-01-20
• Completion: 2026-03-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China