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Completed

NCT Number: NCT07491991

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Jinan, Shandong, 250000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The incidence of postoperative sore throat

    Time frame: within the first 24 postoperative hours

    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.

Secondary outcomes

  1. Four-point scale score for postoperative sore throat

    Time frame: immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively

    The 4-point pain scale is a simple tool for assessing pain intensity using a 0-3 scale:

    0 = no pain,

    • = mild pain,
    • = moderate pain,
    • = severe pain. It is easy to use and suitable for rapid clinical pain evaluation.
  2. Patients' postoperative NRS scores

    Time frame: immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively

    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.

  3. The Anesthesia duration time

    Time frame: From anesthesia induction to departure from the operating room

    The time from the completion of anesthesia induction with tracheal intubation to the end of surgery and departure from the operating room.

  4. Postoperative tracheal catheterization time

    Time frame: end of surgery and admission to the post-anesthesia care unit (PACU) until successful extubation of the endotracheal tube,

    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.

  5. The number of cases with postoperative cough, hoarseness and difficulty in swallowing.

    Time frame: From immediately after extubation to 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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