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

Qianfoshan Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; NEBULIZATION; Thyroid Surgery

Treatments: Other: Inhalation of saline solution via nebulization; Drug: Inhalation of budesonide combined with lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07491991

QianfoshanH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

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.

Treatment:

Drug: Inhalation of budesonide combined with lidocaine

control group

Placebo Comparator group

Description:

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.

Treatment:

Other: Inhalation of saline solution via nebulization