Postoperative PainPhase 4NCT07491991
Effects of Different Drugs for Glottic Atomization on Postoperative Sore Throat After Thyroid Surgery
A Phase 4 study testing Inhalation of budesonide combined with lidocaine and Inhalation of saline solution via nebulization in people with Postoperative Pain and NEBULIZATION, run by Qianfoshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, NEBULIZATION, Thyroid Surgery
- What is being tested?
- Inhalation of budesonide combined with lidocaine and Inhalation of saline solution via nebulization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2025to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250000
About this study
Official 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
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.
Read the 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
- Being tested
- Inhalation of budesonide combined with lidocaine, Inhalation of saline solution via nebulization
- Keywords
- Intraoperative nebulization, Budesonide, Postoperative sore throat, Targeted drug delivery, thyroid surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation of budesonide combined with lidocaineDrug
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 nebulizationOther
After anesthesia induction, tracheal intubation was performed, and the patient received continuous nebulization of 5 mL normal saline at the glottis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Inhalation of saline solution via nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 24 postoperative hours
Secondary outcomes (5)
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,
- = mild pain,
- = moderate pain,
- = severe pain. It is easy to use and suitable for rapid clinical pain evaluation.
Measured: immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From immediately after extubation to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start2 Mar 2025
- Primary completion20 Jan 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Guo, Qianfoshan Hospital
- Investigators
- Liang Guo, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491991
- Sponsor's protocol ID
- QianfoshanH
- Status last verified
- Jan 2025
- First submitted
- 13 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07491991
- Acronym / sponsor ID
- QianfoshanH
- Conditions
- Postoperative Pain, NEBULIZATION, Thyroid Surgery
- Keywords
- Intraoperative nebulization, Budesonide, Postoperative sore throat, Targeted drug delivery, thyroid surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Inhalation of budesonide combined with lidocaineUpon 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. |
| control group | Placebo comparator | Other: Inhalation of saline solution via nebulizationUpon 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation of budesonide combined with lidocaineFollowing 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. | Drug | intervention group |
| Inhalation of saline solution via nebulizationAfter anesthesia induction, tracheal intubation was performed, and the patient received continuous nebulization of 5 mL normal saline at the glottis. | Other | control group |
Primary outcome
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.
5 secondary outcomes
Four-point scale score for postoperative sore throat
Time frame: immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively
Patients' postoperative NRS scores
Time frame: immediately after extubation, 12 hours postoperatively, and 24 hours postoperatively
The Anesthesia duration time
Time frame: From anesthesia induction to departure from the operating room
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,
The number of cases with postoperative cough, hoarseness and difficulty in swallowing.
Time frame: From immediately after extubation to 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang Guo principal investigator
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inhalation of budesonide combined with lidocaine and Inhalation of saline solution via nebulization in people with Postoperative Pain and NEBULIZATION, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative sore throat (time frame: within the first 24 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.