Sore Throat After Thyroid SurgeryNCT07117123
Transcutaneous Electrical Acupoint Stimulation on Postoperative Pharyngeal Pain
A study testing Transcutaneous electrical acupoint stimulation and No electrical stimulation in people with Sore Throat After Thyroid Surgery, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
Thyroid surgery is a common type of surgery in thyroid and breast surgery, mainly used to treat benign and malignant thyroid diseases. Despite the continuous progress in surgical techniques and anesthesia management, postoperative sore throat (POST) is still one of the most common adverse reactions in the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sore Throat After Thyroid Surgery
- What is being tested?
- Transcutaneous electrical acupoint stimulation and No electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Undergoing thyroid surgery under general anesthesia, including both open and endoscopic approaches
- Provision of written informed consent by the patient or a legally authorized representative
Who cannot join
- Failed tracheal intubation or requirement for emergency tracheotomy during surgery
- Requirement for reoperation due to postoperative complications such as bleeding or nerve injury
- Presence of severe cardiopulmonary disease (ASA physical status ≥ IV) or long-term use of corticosteroids
- Incomplete clinical data or inability to complete follow-up
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pharyngeal Pain During Thyroid Surgery Under General Anesthesia
Thyroid surgery is a common type of surgery in thyroid and breast surgery, mainly used to treat benign and malignant thyroid diseases. Despite the continuous progress in surgical techniques and anesthesia management, postoperative sore throat (POST) is still one of the most common adverse reactions in the perioperative period. It is reported that the incidence of POST in patients undergoing general anesthesia is about 15%-62%, while the incidence in the thyroid surgery population can be as high as 68%-80%. POST not only increases the patient's postoperative discomfort, but also may affect swallowing and language functions, prolong hospitalization time, reduce the quality of postoperative recovery, and increase medical costs. Therefore, effectively reducing the incidence and severity of POST is of great significance for improving the prognosis of patients after thyroid surgery.
The mechanism of postoperative sore throat after thyroid surgery is relatively complex, mainly involving two aspects. First, endotracheal intubation is a necessary operation for general anesthesia. The mechanical stimulation, improper airbag pressure, unreasonable catheter model selection, and rough intubation operation can all lead to pharyngeal mucosal damage, congestion, and edema, thereby causing acute POST. Secondly, thyroid surgery itself may also cause pharyngitis, such as traction and compression of the trachea, recurrent laryngeal nerve and pharyngeal soft tissue during surgery, excessive backward tilt of the head and neck during surgery, and local stimulation caused by recurrent laryngeal nerve function monitoring. The above factors work together to cause the incidence and severity of POST in thyroid surgery patients to be significantly higher than other types of surgery.
Read more
At present, measures to reduce POST mainly include reducing the inner diameter of the tracheal tube, controlling the airbag pressure, lubricating the tracheal tube, and using glucocorticoids or local anesthetics, but the effect is limited, and some interventions have the risk of drug side effects. In recent years, transcutaneous electrical acupoint stimulation (TEAS) as a non-invasive and non-traumatic intervention has shown good application prospects in relieving perioperative stress, reducing nausea and vomiting, and promoting gastrointestinal function recovery. Studies have shown that TEAS can effectively relieve a variety of postoperative discomfort symptoms, including laryngeal discomfort and pharyngitis, by regulating the autonomic nervous system, activating the endogenous analgesic system, and reducing the levels of inflammatory factors (such as IL-6 and TNF-α).
Among the many optional acupoints, Lieque (LU7) and Zhaohai (KI6) have been used in the treatment of throat diseases in ancient literature due to their status as "eight meridian intersection points". Modern studies have also confirmed that this acupoint combination has a clear effect on improving throat foreign body sensation, pharyngeal pain and hoarseness. However, there is currently no prospective randomized controlled study focusing on Lieque and Zhaohai acupoints combined with TEAS intervention for people with throat pain after thyroid surgery. Therefore, this study intends to use TEAS intervention on bilateral Lieque and Zhaohai acupoints to comprehensively observe the effect on the incidence and severity of throat pain after thyroid surgery, and evaluate its effect on postoperative nausea and vomiting, anxiety scores and hemodynamic indicators, aiming to provide new non-drug intervention strategies and evidence-based basis for the management of accelerated recovery after thyroid surgery (ERAS).
The goal of this clinical trial is to evaluate whether transcutaneous electrical acupoint stimulation (TEAS) can reduce postoperative sore throat (POST) and improve recovery quality in adult patients undergoing thyroid surgery under general anesthesia.
The main questions it aims to answer are:
Can TEAS at bilateral LU7 (Lieque) and KI6 (Zhaohai) acupoints reduce the incidence and severity of POST within 48 hours after thyroid surgery? Does TEAS influence postoperative nausea and vomiting, anxiety scores, and perioperative hemodynamic stability? Researchers will compare a TEAS group receiving active electrical stimulation at LU7 and KI6 with a control group receiving sham stimulation without current to see if TEAS results in improved postoperative comfort and faster recovery.
Participants will:
Be randomly assigned to TEAS or control group Undergo TEAS or sham stimulation for 30 minutes before induction of anesthesia Receive standard general anesthesia and thyroid surgery Be followed up for 48 hours postoperatively for sore throat assessment, discomfort scores, and related indicators
- Conditions
- Sore Throat After Thyroid Surgery
- Being tested
- Transcutaneous electrical acupoint stimulation, No electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulationDevice
The doctor will stick special electrodes on your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect the electrical stimulation device (Han's Pain Treatment Device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and provided by this project team). The current intensity will gradually increase from a small amount to the maximum level you can tolerate (starting from 1mA, not exceeding the maximum safety range of 10mA). The entire transcutaneous acupoint electrical stimulation lasts for 30 minutes. This electrical stimulation is non-traumatic and painless. Most people only feel slight numbness, swelling, and heat.
No electrical stimulationOther
The doctor will attach special electrodes to your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect them to an electrical stimulation device (Han's pain treatment device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and is provided by this project team). No electricity (i.e. no stimulation)
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | If you are randomly assigned to the transcutaneous electrical acupoint stimulation (TEAS) group, after you enter the anesthesia preparation, the doctor will stick special electrodes on your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect the electrical stimulation device (Han's Pain Treatment Device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and provided by this project team). The current intensity will gradually increase from a small amount to the maximum level you can tolerate (starting from 1mA, not exceeding the maximum safety range of 10mA). The entire transcutaneous electrical acupoint stimulation lasts for 30 minutes. This electrical stimulation is non-traumatic and painless. Most people only feel slight numbness, swelling, and heat. Receives: Device: Transcutaneous electrical acupoint stimulation |
| Control group | Placebo comparator | Electrodes were applied to the same acupoints (bilateral Lieque and Zhaohai points), but no electrical stimulation was performed. Other operations were consistent with those in the intervention group. Receives: Other: No electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Sore Throat (POST) at 24 Hours After Extubation
The percentage of patients who report a POST score >1 at 24 hours following thyroid surgery under general anesthesia.
Scoring Criteria:
0 = No sore throat at any time after surgery
- = Mild sore throat (pain only on swallowing)
- = Moderate sore throat (pain at rest and worsens with swallowing)
- = Severe sore throat (requires analgesics or affects eating) Definition of Event: POST score >1 is defined as a positive occurrence.
Measured: 24 hours after extubation
Secondary outcomes (4)
Incidence and Severity of POST at 1, 6, and 48 Hours After Extubation
Measured: 1 hour, 6 hours, and 48 hours after extubation
Incidence of Hoarseness of Voice (HOV) at 1, 6, 24, and 48 Hours After Extubation
Measured: 1 hour, 6 hours, 24 hours, and 48 hours after extubation
Duration of POST
Time from onset to complete resolution of postoperative sore throat symptoms, as recorded by the patient and confirmed by the investigator.
Measured: Perioperative/Periprocedural
Incidence of Postoperative Nausea and Vomiting
PONV incidence is defined as the occurrence of at least one of the following within the first 48 hours after surgery:
- Clinically significant nausea - Nausea severity measured using the Numerical Rating Scale for Nausea (0 to 10 points), where 0 = "No nausea" and 10 = "Worst imaginable nausea." A score of ≥ 4 is considered clinically significant nausea, indicating moderate or greater severity and potentially requiring antiemetic treatment.
- Vomiting or retching episodes - Any expulsion of gastric contents (vomiting) or heaving without expulsion (retching). Recorded as count data (integer ≥ 0).
- Use of rescue antiemetic medication - Administration of any antiemetic drug for treatment of nausea or vomiting within the observation period.
Scale information:
- Numerical Rating Scale for Nausea:
- Minimum score: 0
- Maximum score: 10 Higher scores indicate worse nausea severity
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore Throat After Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoLiang Wang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117123
- Sponsor's protocol ID
- KY20250624-13
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pharyngeal Pain During Thyroid Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07117123
- Acronym / sponsor ID
- KY20250624-13
- Conditions
- Sore Throat After Thyroid Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 12 Aug 2025 (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.
Thyroid surgery is a common type of surgery in thyroid and breast surgery, mainly used to treat benign and malignant thyroid diseases. Despite the continuous progress in surgical techniques and anesthesia management, postoperative sore throat (POST) is still one of the most common adverse reactions in the perioperative period. It is reported that the incidence of POST in patients undergoing general anesthesia is about 15%-62%, while the incidence in the thyroid surgery population can be as high as 68%-80%. POST not only increases the patient's postoperative discomfort, but also may affect swallowing and language functions, prolong hospitalization time, reduce the quality of postoperative recovery, and increase medical costs. Therefore, effectively reducing the incidence and severity of POST is of great significance for improving the prognosis of patients after thyroid surgery.
The mechanism of postoperative sore throat after thyroid surgery is relatively complex, mainly involving two aspects. First, endotracheal intubation is a necessary operation for general anesthesia. The mechanical stimulation, improper airbag pressure, unreasonable catheter model selection, and rough intubation operation can all lead to pharyngeal mucosal damage, congestion, and edema, thereby causing acute POST. Secondly, thyroid surgery itself may also cause pharyngitis, such as traction and compression of the trachea, recurrent laryngeal nerve and pharyngeal soft tissue during surgery, excessive backward tilt of the head and neck during surgery, and local stimulation caused by recurrent laryngeal nerve function monitoring. The above factors work together to cause the incidence and severity of POST in thyroid surgery patients to be significantly higher than other types of surgery.
At present, measures to reduce POST mainly include reducing the inner diameter of the tracheal tube, controlling the airbag pressure, lubricating the tracheal tube, and using glucocorticoids or local anesthetics, but the effect is limited, and some interventions have the risk of drug side effects. In recent years, transcutaneous electrical acupoint stimulation (TEAS) as a non-invasive and non-traumatic intervention has shown good application prospects in relieving perioperative stress, reducing nausea and vomiting, and promoting gastrointestinal function recovery. Studies have shown that TEAS can effectively relieve a variety of postoperative discomfort symptoms, including laryngeal discomfort and pharyngitis, by regulating the autonomic nervous system, activating the endogenous analgesic system, and reducing the levels of inflammatory factors (such as IL-6 and TNF-α).
Among the many optional acupoints, Lieque (LU7) and Zhaohai (KI6) have been used in the treatment of throat diseases in ancient literature due to their status as "eight meridian intersection points". Modern studies have also confirmed that this acupoint combination has a clear effect on improving throat foreign body sensation, pharyngeal pain and hoarseness. However, there is currently no prospective randomized controlled study focusing on Lieque and Zhaohai acupoints combined with TEAS intervention for people with throat pain after thyroid surgery. Therefore, this study intends to use TEAS intervention on bilateral Lieque and Zhaohai acupoints to comprehensively observe the effect on the incidence and severity of throat pain after thyroid surgery, and evaluate its effect on postoperative nausea and vomiting, anxiety scores and hemodynamic indicators, aiming to provide new non-drug intervention strategies and evidence-based basis for the management of accelerated recovery after thyroid surgery (ERAS).
The goal of this clinical trial is to evaluate whether transcutaneous electrical acupoint stimulation (TEAS) can reduce postoperative sore throat (POST) and improve recovery quality in adult patients undergoing thyroid surgery under general anesthesia.
The main questions it aims to answer are:
Can TEAS at bilateral LU7 (Lieque) and KI6 (Zhaohai) acupoints reduce the incidence and severity of POST within 48 hours after thyroid surgery? Does TEAS influence postoperative nausea and vomiting, anxiety scores, and perioperative hemodynamic stability? Researchers will compare a TEAS group receiving active electrical stimulation at LU7 and KI6 with a control group receiving sham stimulation without current to see if TEAS results in improved postoperative comfort and faster recovery.
Participants will:
Be randomly assigned to TEAS or control group Undergo TEAS or sham stimulation for 30 minutes before induction of anesthesia Receive standard general anesthesia and thyroid surgery Be followed up for 48 hours postoperatively for sore throat assessment, discomfort scores, and related indicators
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: Transcutaneous electrical acupoint stimulationIf you are randomly assigned to the transcutaneous electrical acupoint stimulation (TEAS) group, after you enter the anesthesia preparation, the doctor will stick special electrodes on your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect the electrical stimulation device (Han's Pain Treatment Device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and provided by this project team). The current intensity will gradually increase from a small amount to the maximum level you can tolerate (starting from 1mA, not exceeding the maximum safety range of 10mA). The entire transcutaneous electrical acupoint stimulation lasts for 30 minutes. This electrical stimulation is non-traumatic and painless. Most people only feel slight numbness, swelling, and heat. |
| Control group | Placebo comparator | Other: No electrical stimulationElectrodes were applied to the same acupoints (bilateral Lieque and Zhaohai points), but no electrical stimulation was performed. Other operations were consistent with those in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Undergoing thyroid surgery under general anesthesia, including both open and endoscopic approaches
- Provision of written informed consent by the patient or a legally authorized representative
Key exclusion criteria (4 listed)
- Failed tracheal intubation or requirement for emergency tracheotomy during surgery
- Requirement for reoperation due to postoperative complications such as bleeding or nerve injury
- Presence of severe cardiopulmonary disease (ASA physical status ≥ IV) or long-term use of corticosteroids
- Incomplete clinical data or inability to complete follow-up
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 |
|---|---|---|
| Transcutaneous electrical acupoint stimulationThe doctor will stick special electrodes on your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect the electrical stimulation device (Han's Pain Treatment Device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and provided by this project team). The current intensity will gradually increase from a small amount to the maximum level you can tolerate (starting from 1mA, not exceeding the maximum safety range of 10mA). The entire transcutaneous acupoint electrical stimulation lasts for 30 minutes. This electrical stimulation is non-traumatic and painless. Most people only feel slight numbness, swelling, and heat. | Device | TEAS group |
| No electrical stimulationThe doctor will attach special electrodes to your wrist (Lieque point) and the inside of your ankle (Zhaohai point), and connect them to an electrical stimulation device (Han's pain treatment device, Nanjing Jisheng Medical Technology Co., Ltd., which has been clinically used and is provided by this project team). No electricity (i.e. no stimulation) | Other | Control group |
Primary outcome
Incidence of Postoperative Sore Throat (POST) at 24 Hours After Extubation
Time frame: 24 hours after extubation
The percentage of patients who report a POST score >1 at 24 hours following thyroid surgery under general anesthesia. Scoring Criteria: 0 = No sore throat at any time after surgery 1. = Mild sore throat (pain only on swallowing) 2. = Moderate sore throat (pain at rest and worsens with swallowing) 3. = Severe sore throat (requires analgesics or affects eating) Definition of Event: POST score >1 is defined as a positive occurrence.
4 secondary outcomes
Incidence and Severity of POST at 1, 6, and 48 Hours After Extubation
Time frame: 1 hour, 6 hours, and 48 hours after extubation
Incidence of Hoarseness of Voice (HOV) at 1, 6, 24, and 48 Hours After Extubation
Time frame: 1 hour, 6 hours, 24 hours, and 48 hours after extubation
Duration of POST
Time frame: Perioperative/Periprocedural
Incidence of Postoperative Nausea and Vomiting
Time frame: Within 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical acupoint stimulation and No electrical stimulation in people with Sore Throat After Thyroid Surgery, run by Nanjing First Hospital, Nanjing Medical University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Postoperative Sore Throat (POST) at 24 Hours After Extubation (time frame: 24 hours after extubation). 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 12 Aug 2025.