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

NCT07491991 | Completed Phase 4

• 1 other identifier: QianfoshanH
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; NEBULIZATION; Thyroid Surgery

Keywords

Intraoperative nebulization; Budesonide; Postoperative sore throat; Targeted drug delivery; thyroid surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Four-point scale score for postoperative sore throat

  immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively

• Patients' postoperative NRS scores

  immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively

• The Anesthesia duration time

  From anesthesia induction to departure from the operating room

• Postoperative tracheal catheterization time

  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

Study Arms (2)

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.

Drug: Inhalation of budesonide combined with lidocaine

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.

Other: Inhalation of saline solution via nebulization

Interventions

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.

intervention group

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.

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Liang Guo

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Senior Physician

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 25, 2026
• Study Start: March 2, 2025
• Primary Completion: January 20, 2026
• Study Completion: March 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-01

Locations

CN (1)