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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Upon arrival in the operating room, routine monitoring was performed on the participants, including electrocardiogram (ECG), pulse oxygen saturation (SpO₂), non-invasive blood pressure (NIBP), and skin temperature, together with bispectral index (BIS) monitoring for anesthetic depth. Anesthesia induction was conducted with midazolam 0.03 mg/kg, sufentanil 0.4 μg/kg, etomidate 0.4 mg/kg, and atracurium 0.6 mg/kg. After pre-oxygenation via face mask, tracheal intubation was performed, and the patient was connected to the anesthesia machine. Then, 1 mL budesonide plus 4 mL lidocaine was administered by nebulization at the glottis. Anesthesia maintenance was achieved with target-controlled infusion of propofol at 0.5-2 μg/mL and remifentanil at 0.2-0.3 μg/kg/min, maintaining the BIS value between 40 and 60. |
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| control group | Placebo Comparator | Upon arrival in the operating room, routine monitoring was performed on the participants, including electrocardiogram (ECG), pulse oxygen saturation (SpO₂), non-invasive blood pressure (NIBP), skin temperature, and bispectral index (BIS) monitoring for anesthetic depth. Anesthesia induction was conducted with midazolam 0.03 mg/kg, sufentanil 0.4 μg/kg, etomidate 0.4 mg/kg, and atracurium 0.6 mg/kg. After pre-oxygenation via face mask, tracheal intubation was performed, and the participants were connected to the anesthesia machine. 5 mL of normal saline was administered by nebulization at the glottis. Anesthesia maintenance was achieved with target-controlled infusion of propofol at 0.5-2 μg/mL and remifentanil at 0.2-0.3 μg/kg/min, maintaining the BIS value between 40 and 60. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalation of budesonide combined with lidocaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postoperative sore throat | Postoperative sore throat (POST) is one of the common complications following general anesthesia with endotracheal intubation, with a reported incidence of 30% to 70%. Severe POST, accompanied by cough, hoarseness, dysphagia, and other symptoms, significantly reduces patients' postoperative comfort and satisfaction, and is detrimental to rapid postoperative recovery. | within the first 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Four-point scale score for postoperative sore throat | The 4-point pain scale is a simple tool for assessing pain intensity using a 0-3 scale: 0 = no pain,
| immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liang Guo | Qianfoshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University | Jinan | Shandong | 250000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2025 |
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| Inhalation of saline solution via nebulization | Other | After anesthesia induction, tracheal intubation was performed, and the patient received continuous nebulization of 5 mL normal saline at the glottis. |
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| Patients' postoperative NRS scores | The NRS is an 11-point numerical pain assessment scale that uses 11 numbers ranging from 0 to 10 to represent the intensity of pain from no pain to the most severe pain. Patients select the corresponding number based on their own pain perception to quantify pain intensity, making it one of the most commonly used tools for perioperative and postoperative pain evaluation. | immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively |
| The Anesthesia duration time | The time from the completion of anesthesia induction with tracheal intubation to the end of surgery and departure from the operating room. | From anesthesia induction to departure from the operating room |
| Postoperative tracheal catheterization time | Refers to the time interval from the end of surgery and admission to the post-anesthesia care unit (PACU) until successful extubation of the endotracheal tube, usually measured in minutes. It is an important indicator for evaluating airway management, postoperative recovery, and extubation safety. | end of surgery and admission to the post-anesthesia care unit (PACU) until successful extubation of the endotracheal tube, |
| The number of cases with postoperative cough, hoarseness and difficulty in swallowing. | From immediately after extubation to 24 hours postoperatively |
| Mar 18, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 5, 2025 | Mar 18, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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