ThyroidectomyNCT07641673
The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery
A study testing Esketamine（iv）, ESK spray and Normal Saline in people with Thyroidectomy and Coughing Reflex, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
This study intends to implement esketamine-assisted anesthesia in patients undergoing non-inflatable transoral endoscopic thyroidectomy through a prospective randomized controlled trial, in order to observe the effect of esketamine on coughing during extubation in thyroidectomy patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroidectomy, Coughing Reflex
- What is being tested?
- Esketamine（iv）, ESK spray and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Sep 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for endotracheal intubation-free thyroid surgery under oral endoscopy
- ASA class I-II
- Voluntarily participate in the study and sign the informed consent form
Who cannot join
- Body Mass Index > 30 kg/m²
- Patients with unstable ischemic cardiomyopathy, pulmonary hypertension, poorly controlled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure >180/100 mmHg)
- Hepatic or renal dysfunction
- History of oral, maxillofacial, neck, or airway surgery, or pathological structural alterations
- Respiratory diseases (COPD, asthma, inflammation, chronic cough)
- Patients with elevated intracranial pressure
Show all 9Show fewer
- Patients undergoing repeat surgery
- History of allergy to the investigational drug used in the study
- Patients with psychiatric disorders or alcohol abuse (daily ethanol intake ≥40 g, or having experienced alcohol withdrawal within the past 6 months, or unable to control alcohol consumption)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Yun Wu, 8613865958254, wuyunanyi@163.com
About this study
Official title: The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery: A Randomized Controlled Study.
This study intends to implement esketamine-assisted anesthesia in patients undergoing non-inflatable transoral endoscopic thyroidectomy through a prospective randomized controlled trial, in order to observe the effect of esketamine on coughing during extubation in thyroidectomy patients.
- Conditions
- Thyroidectomy, Coughing Reflex
- Being tested
- Esketamine（iv）, ESK spray, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine（iv）Drug
During anesthesia induction, administer esketamine intravenously at 0.5 mg/kg. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray physiological saline (3 ml) above the glottis, at the glottis, and below the glottis.
ESK sprayDrug
During anesthesia induction, Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray esketamine at the supraglottic, glottic, and subglottic levels: 3 ml (0.5 mg/kg).
Normal SalineDrug
During anesthesia induction, intravenous injection of an equal amount of normal saline is administered. After achieving muscle relaxation, under direct laryngoscopic view, spray normal saline over the supraglottic, glottic, and subglottic areas: 3 ml.
| Study group | Role | What they receive |
|---|---|---|
| ESK iv group | Experimental | During anesthesia induction, administer esketamine intravenously at 0.5 mg/kg. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray physiological saline (3 ml) above the glottis, at the glottis, and below the glottis. Receives: Drug: Esketamine（iv） |
| ESK spray group | Experimental | During anesthesia induction, intravenously inject an equal amount of normal saline. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray esketamine at the supraglottic, glottic, and subglottic levels: 3 ml (0.5 mg/kg). Receives: Drug: ESK spray |
| CON group | Placebo comparator | During anesthesia induction, intravenous injection of an equal amount of normal saline is administered. After achieving muscle relaxation, under direct laryngoscopic view, spray normal saline over the supraglottic, glottic, and subglottic areas: 3 ml. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coughing during tracheal extubation
0=None; 0 = Did not occur; 1 = Occurred;
Measured: Perioperative (From the awakening period to immediately after tracheal extubation)
Secondary outcomes (34)
Severity of coughing during tracheal extubation
Grade 0: No choking cough; Grade 1: Single cough episode, considered mild choking cough; Grade 2: Intermittent cough, lasting less than 5 seconds, considered moderate choking cough; Grade 3: Continuous severe cough, lasting more than 5 seconds, considered severe choking cough; The higher the degree, the worse it is.
Measured: Perioperative (From the awakening period to immediately after tracheal extubation)
Agitation score during tube removal
1: Awake and calm; 2: Mild agitation but can be comforted; 3: Moderate agitation, difficult to comfort; 4: Severe agitation, cannot be comforted; The higher the degree, the worse the situation.
Measured: Perioperative (From the awakening period to immediately after tracheal extubation)
Blood pressure
Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
Measured: Perioperative (From the induction period until 5 minutes after the completion of surgery)
Airway pressure 5 minutes after intubation and at the end of surgery
Measured: 5 minutes after intubation and at the end of the surgery.
Intraoperative use rate and dosage of vasoactive drugs
Measured: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of sufentanil
Measured: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative fluid volume
Measured: Intraoperative (From the induction period to the end of anesthesia)
Sore throat score
0 = None; 1 = Mild, milder than a common cold; 2 = Moderate, like a sore throat from a common cold; 3 = Severe, more severe than a common cold; The higher the score, the greater the level of pain.
Measured: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
Surgical area pain scores
Pain NRS scale score: 0 = no pain; 1-3 = mild pain; 4-6 = moderate pain; 7-10 = severe pain; The higher the score, the more severe the pain.
Measured: Postoperative 24 hours and 48 hours.
Incidence of adverse reactions
Measured: Within 48 hours after surgery
Postoperative nausea and vomiting(PONV) score
Vomiting: 0 = None; 1 = Once; 2 = Twice; 3 = Three times or more Nausea, does it affect daily life: 0 = None; 1 = Sometimes; 2 = Often; 3 = Always
Measured: Within 48 hours after surgery.
Postoperative analgesic dosage
Measured: Within day 2 after surgery
Postoperative time to first food
Measured: Perioperative (Time from returning to the ward to the first food)
Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score
Upper Aerodigestive Symptoms After Thyroidectomy Questionnaire; Instructions: 0=No problem, 1=Minor, 2=Moderate, 3=Major. Voice symptoms
- Vocal fatigue
- Difficulty speaking loudly
- Roughness
- Voice in low pitch
- Can"t speak in high pitch
- Voice in high pitch Swallowing/pharyngeal symptoms
- Burning during swallowing
- Pharyngeal bolus
- Pain during deglutition
- Pharyngeal pain
- Choking
- Dry throat
- Discomfort during swallowing
- Throat clearing
- Neck scar retraction during deglutition
- Foreign body sensation in pharynx
- Strangling sensation during swallowing
- Coughing during swallowing
- Foreign body in pharynx; The higher the score, the more severe it is.
Measured: One month after surgery
Heart rate
Baseline, post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
Measured: From the induction period until 5 minutes after the completion of surgery.
Oxygen saturation
Baseline , post-induction, 1 minute after intubation, at the end of the surgery, 1 minute after extubation, and 5 minutes after extubation.
Measured: Intraoperative (From the induction period until 5 minutes after the completion of surgery)
Intraoperative doses of propofol
Measured: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of remifentanil
Measured: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
Measured: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative blood loss
Measured: Intraoperative (From the induction period to the end of anesthesia)
Anesthesia time
Measured: Time from induction to discontinuation of anesthetic agents.
Surgery time
Measured: From the start of surgery to the end of surgery.
Endotracheal tube indwelling time
Measured: Perioperative (Time from intubation to extubation)
Awakening time
Measured: Perioperative (Stop the anesthesia drug injection until awakening time)
Extubation time
Measured: Perioperative (The time from discontinuation of anesthetic drugs to extubation)
Post-anesthesia care unit (PACU) stay time
Measured: Perioperative (Duration from entering the PACU to leaving the PACU)
Hoarseness scores
0 = None; 1 = Transient hoarseness occurs; 2 = Patient perceives hoarseness during visit; 3 = Hoarseness is clearly noticeable; The higher the score, the more severe the hoarseness.
Measured: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
Sleep scores
1 = Good sleep; 2 = Restless sleep; 3 = Dreamy sleep; 4 = Insomnia; The higher the score, the poorer the sleep.
Measured: Postoperative 24 hours and 48 hours.
Numbness scores
Numbness Score: 0 = None; 1-3: Mild numbness, occasionally perceived, does not affect daily activities; 4-6: Moderate numbness, persistent numbness with slight discomfort, affecting some eating/speaking; 7-10: Severe numbness, strong numbness or complete loss of sensation, severely affecting daily life. The higher the score, the greater the level of numbness.
Measured: Postoperative 24h and 48h.
PACU RASS score
- 4: Combative
- 3: Very agitated
- 2: Agitated
- 1: Restless 0: Alert and calm
- 1: Drowsy
- 2: Light sedation
- 3: Moderate sedation
- 4: Deep sedation
- 5: Unarousable
Measured: Perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room)
Postoperative analgesic dosage
Measured: Within 48 hours after surgery
Postoperative time to first water intake
Measured: Perioperative (Time from returning to the ward to the first drink of water)
Postoperative time to ambulation
Measured: Perioperative (From the operating room to discharge)
Length of postoperative hospital stay
Measured: Perioperative (From the operating room to discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Wu, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641673
- Sponsor's protocol ID
- YX2026-095(F1)
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esketamine on Cough Reflex During Tracheal Extubation in Patients Undergoing Non-inflatable Transoral Endoscopic Thyroid Surgery: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07641673
- Acronym / sponsor ID
- YX2026-095(F1)
- Conditions
- Thyroidectomy, Coughing Reflex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Jun 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.
This study intends to implement esketamine-assisted anesthesia in patients undergoing non-inflatable transoral endoscopic thyroidectomy through a prospective randomized controlled trial, in order to observe the effect of esketamine on coughing during extubation in thyroidectomy patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESK iv group | Experimental | Drug: Esketamine（iv）During anesthesia induction, administer esketamine intravenously at 0.5 mg/kg. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray physiological saline (3 ml) above the glottis, at the glottis, and below the glottis. |
| ESK spray group | Experimental | Drug: ESK sprayDuring anesthesia induction, intravenously inject an equal amount of normal saline. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray esketamine at the supraglottic, glottic, and subglottic levels: 3 ml (0.5 mg/kg). |
| CON group | Placebo comparator | Drug: Normal SalineDuring anesthesia induction, intravenous injection of an equal amount of normal saline is administered. After achieving muscle relaxation, under direct laryngoscopic view, spray normal saline over the supraglottic, glottic, and subglottic areas: 3 ml. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for endotracheal intubation-free thyroid surgery under oral endoscopy
- ASA class I-II
- Voluntarily participate in the study and sign the informed consent form
Key exclusion criteria (9 listed)
- Body Mass Index > 30 kg/m²
- Patients with unstable ischemic cardiomyopathy, pulmonary hypertension, poorly controlled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure >180/100 mmHg)
- Hepatic or renal dysfunction
- History of oral, maxillofacial, neck, or airway surgery, or pathological structural alterations
- Respiratory diseases (COPD, asthma, inflammation, chronic cough)
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 |
|---|---|---|
| Esketamine（iv）During anesthesia induction, administer esketamine intravenously at 0.5 mg/kg. Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray physiological saline (3 ml) above the glottis, at the glottis, and below the glottis. | Drug | ESK iv group |
| ESK sprayDuring anesthesia induction, Once muscle relaxation is achieved, under direct laryngoscopic visualization, spray esketamine at the supraglottic, glottic, and subglottic levels: 3 ml (0.5 mg/kg). | Drug | ESK spray group |
| Normal SalineDuring anesthesia induction, intravenous injection of an equal amount of normal saline is administered. After achieving muscle relaxation, under direct laryngoscopic view, spray normal saline over the supraglottic, glottic, and subglottic areas: 3 ml. | Drug | CON group |
Primary outcome
Incidence of coughing during tracheal extubation
Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)
0=None; 0 = Did not occur; 1 = Occurred;
34 secondary outcomes
Severity of coughing during tracheal extubation
Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)
Agitation score during tube removal
Time frame: Perioperative (From the awakening period to immediately after tracheal extubation)
Blood pressure
Time frame: Perioperative (From the induction period until 5 minutes after the completion of surgery)
Airway pressure 5 minutes after intubation and at the end of surgery
Time frame: 5 minutes after intubation and at the end of the surgery.
Intraoperative use rate and dosage of vasoactive drugs
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of sufentanil
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative fluid volume
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Sore throat score
Time frame: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
Surgical area pain scores
Time frame: Postoperative 24 hours and 48 hours.
Incidence of adverse reactions
Time frame: Within 48 hours after surgery
Postoperative nausea and vomiting(PONV) score
Time frame: Within 48 hours after surgery.
Postoperative analgesic dosage
Time frame: Within day 2 after surgery
Postoperative time to first food
Time frame: Perioperative (Time from returning to the ward to the first food)
Upper Aerodigestive Symptoms After Thyroidectomy (UADS) questionnaire score
Time frame: One month after surgery
Heart rate
Time frame: From the induction period until 5 minutes after the completion of surgery.
Oxygen saturation
Time frame: Intraoperative (From the induction period until 5 minutes after the completion of surgery)
Intraoperative doses of propofol
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of remifentanil
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative doses of Non-Steroidal Anti-Inflammatory Drugs(NSAIDs)
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Intraoperative blood loss
Time frame: Intraoperative (From the induction period to the end of anesthesia)
Anesthesia time
Time frame: Time from induction to discontinuation of anesthetic agents.
Surgery time
Time frame: From the start of surgery to the end of surgery.
Endotracheal tube indwelling time
Time frame: Perioperative (Time from intubation to extubation)
Awakening time
Time frame: Perioperative (Stop the anesthesia drug injection until awakening time)
Extubation time
Time frame: Perioperative (The time from discontinuation of anesthetic drugs to extubation)
Post-anesthesia care unit (PACU) stay time
Time frame: Perioperative (Duration from entering the PACU to leaving the PACU)
Hoarseness scores
Time frame: Baseline, Immediately postoperatively, 0.5 hours postoperatively, 2 hours postoperatively, 24 hours postoperatively, 48 hours postoperatively.
Sleep scores
Time frame: Postoperative 24 hours and 48 hours.
Numbness scores
Time frame: Postoperative 24h and 48h.
PACU RASS score
Time frame: Perioperative (Record once every ten minutes from the time of entering the post-anesthesia care unit until leaving the recovery room)
Postoperative analgesic dosage
Time frame: Within 48 hours after surgery
Postoperative time to first water intake
Time frame: Perioperative (Time from returning to the ward to the first drink of water)
Postoperative time to ambulation
Time frame: Perioperative (From the operating room to discharge)
Length of postoperative hospital stay
Time frame: Perioperative (From the operating room to discharge)
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 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine（iv）, ESK spray and Normal Saline in people with Thyroidectomy and Coughing Reflex, run by The Second Hospital of Anhui Medical University 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 3 inclusion and 9 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 11 Jun 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.
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?
Contact Yun Wu (8613865958254, wuyunanyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coughing during tracheal extubation (time frame: Perioperative (From the awakening period to immediately after tracheal 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 11 Jun 2026.